111 155

111. Acta Med Iran. 2015;53(9):573-8.
Effect of Zolpidem on Sleep Quality of Professional Firefighters; a Double Blind,

Randomized, Placebo-Controlled Crossover Clinical Trial.
Mehrdad R(1), Sadeghniiat Haghighi K(2), Naseri Esfahani AH(3).
Author information:
(1)Department of Occupational Medicine, Center for Research on Occupational
Diseases, Tehran University of Medical Sciences, Tehran, Iran.
(2)Department of Occupational Medicine, Occupational Sleep Research Center
(OSRC), Tehran University of Medical Sciences, Tehran, Iran.
(3)Department of Occupational Medicine, School of Medicine, Hormozgan University
of Medical Sciences, Bandar Abbas, Iran.
Professional firefighting is among the most demanding jobs. Prior studies have
showed the notable prevalence of poor sleep quality among professional
firefighters that may result in catastrophes. The aim of this study was in field
confirmation of zolpidem usage (10 mg/PO/bed time) for short term management of
poor sleeps quality among professional firefighters. In a double-blind,
randomized, placebo-controlled crossover clinical trial among professional
firefighters, 27 poor sleepers were assigned randomly to one of the two groups.
Two 14 days experimental periods were separated by a 14-day washout phase. Sleep
quality was assessed using the Persian version of Pittsburgh Sleep Quality Index
(PSQI). Six of the 27 enrolled voluntaries dropped out. Two rare side effects of
zolpidem occurred in the study. A significant improvement of the PSQI score was
detected in zolpidem period versus placebo in both groups (7.14 ± 3.02 vs 12.38 ±
2.51, P<0.001) although zolpidem had no significant effect on time of waking up
(6.76 ± 1.21 vs.6.64 ± 1.27, P=0.89). Zolpidem significantly improved all
components of PSQI (Subjective sleep quality, Sleep latency, Sleep duration,
Habitual sleep efficiency, Sleep disturbances and Daytime dysfunction) in the
current study except the use of sleep medication. Sleep onset latency was the
component of PSQI with the greatest degree of abnormality among firefighters in a
previous study. Interestingly, sleep latency was the component of PSQI with the
most treatment effect of zolpidem in the current study. Zolpidem can be used asa
part of treatment regimens in short time management of poor sleep quality among
professional firefighters.
PMID: 26553086 [Indexed for MEDLINE]
112. Int Heart J. 2017 Oct 21;58(5):752-761. doi: 10.1536/ihj.16-511. Epub 2017 Sep
30.
Association Between Blood Pressure Lowering and Quality of Life by Treatment of

Azilsartan.
Fujiwara N(1), Tanaka A(1), Kawaguchi A(2), Tago M(1), Oyama JI(1), Uchida Y(3),
Matsunaga K(4), Moroe K(5), Toyoda S(6), Inoue T(6), Ikeda H(7), Node K(1); APEQ
Study Investigators.
Author information:
(1)Department of Cardiovascular Medicine, Saga University.
(2)Center for Comprehensive Community Medicine, Saga University.
(3)Department of Gastroenterology, Saga Memorial Hospital.
(4)Department of Internal Medicine, Imari-Arita Hospital.
(5)Department of Cardiovascular Medicine, Moroe Cardiovascular Clinic.
(6)Department of Cardiovascular Medicine, Dokkyo Medical University.
(7)Department of Internal Medicine, Ikeda Naika Hifuka Clinic.
The authors assessed the effects of switching from a conventional angiotensin II

receptor blocker (ARB) to azilsartan on blood pressure (BP) and health-related
quality of life (HR-QOL) in patients with uncontrolled hypertension. Key
eligibility criteria were uncontrolled hypertension treated for ≥ 1 month with an
ARB, excluding azilsartan, that did not reach the target BP. We recruited 147
patients (64 males and 83 females; mean ± standard deviation age 73 ± 15 years).
Azilsartan reduced both systolic and diastolic BP significantly, from 151 ± 16/82
± 12 to 134 ± 17/73 ± 12 mm Hg, 3 months after switching. Although scores on the
comprehensive QOL scale, the EuroQoL 5 dimensions (EQ5D), and the simplified
menopausal index (SMI) did not change, the Geriatric Depression Scale (GDS) score
improved significantly, and there was a significant association between the
change in the GDS score and systolic BP lowering (r = 0.2554, P = 0.030). The
Pittsburgh sleep quality index (PSQI) improved significantly only in the female
subgroup. Besides sufficient BP lowering activity, anti-hypertensive treatment
with azilsartan may have a favorable impact on depression in geriatric patients
with uncontrolled hypertension.
DOI: 10.1536/ihj.16-511
113. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2018 Nov 28;43(11):1230-1235. doi:
10.11817/j.issn.1672-7347.2018.11.010.
[Efficacy of fluvoxamine combined with extended-release methylphenidate on

treatment-refractory obsessive-compulsive disorder].
[Article in Chinese; Abstract available in Chinese from the publisher]
Zheng H(1), Jia F(2), Guo G(2), Quan D(2), Li G(2), Huang H(3).
Author information:
(1)Guangdong Mental Health Center, Guangdong General Hospital, Guangdong Academy
of Medical Sciences, Guangzhou 510080, China hgm198103@163.com.
(2)Guangdong Mental Health Center, Guangdong General Hospital, Guangdong Academy
of Medical Sciences, Guangzhou 510080, China.
(3)Department of Pharmacy, Guangdong General Hospital, Guangdong Academy of
Medical Sciences, Guangzhou 510080, China.
OBJECTIVE: To observe the clinical efficacy of dopamine modulator methylphenidate

(MPH) of extended-release formulations (MPH-ER) augmentation of ongoing
fluvoxamine treatment in refractory obsessive-compulsive disorder (OCD) and its
effects on patient's anxiety and sleep quality. Methods: A pilot randomized,
placebo-controlled, and double-blind trial was conducted at an outpatient,
single-center academic setting. Participants included 44 adults with serotonin
reuptake inhibitor treatment-refractory OCD and they received a stable
fluvoxamine pharmacotherapy with Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
scores higher than 20. The 44 patients were randomly assigned into a study group
and a control group, with 22 patiencs in each group. Fluvoxamine and MPH-ER were
given to the study group, while fluvoxamine and placebo were given to the control
group, with 8 weeks of the treatment course. Y-BOCS, Hamilton Anxiety Scale
(HAMA) were used to assess the efficacy, Pittsburgh Sleep Quality Index (PSQI)
was used to evaluate the sleep quality, and Treatment Emergent Symptom Scale
(TESS) was used to evaluate the side effects. Data were analyzed in the
intention-to-treat sample. Results: The improvement in the Y-BOCS total score,
Y-BOCS obsession subscale score and HAMA score were more prominent in the study
group than those in the control group (P<0.001). There was no significant
difference in PSQI score and TESS score between the two groups. MPH-ER was well
tolerated. Conclusion: Fluvoxamine combined with MPH-ER is effective in the
treatment of refractory obsessive-compulsive disorder. It can improve anxiety and
has no adverse effect on sleep quality.
Publisher:
目的：观察氟伏沙明联合长效哌甲酯治疗难治性强迫症的临床效果，探讨该治疗对患
者焦虑情绪和睡眠质量的影响。方法：采取随机、双盲、安慰剂对照研究，将 44 例强
迫症患者随机
分成两组，每组 22 例，研究组服用氟伏沙明和长效哌甲酯缓释片，对照组服用氟伏沙
明和安慰剂，随访时间均为 8 周。采用耶鲁-布朗强迫症状量表(Yale-Brown
Obsessive Compulsive Scale，Y-BOCS)、汉密尔顿焦虑量表(Hamilton Anxiety
Scale，HAMA)评定临床疗效，采用匹兹堡睡眠质量指数量表(Pittsburgh Sleep Quality
Index，PSQI)评定睡眠质量，采用不良反应量表(Treatment Emergent Symptom
Scale，TESS)评定不良反应。结果：研究组治疗总有效率高于对照组，差异有统计学意
义(P<0.05)。治疗第 8 周末两组 Y-BOCS，HAMA
评分比较差异有统计学意义(P<0.05)，两组
PSQI 评分差异无统计学意义(P>0.05)。TESS 评分在治疗第 2，4，6，8 周末差异均无统
计学意义(P>0.05)。结论：氟伏沙明联合长效哌甲酯治疗难治性强迫
症具有较好的疗效，可改善患者的焦虑情绪，对患者睡眠质量无影响，安全性较好，
值得进一步在临床推广。.
DOI: 10.11817/j.issn.1672-7347.2018.11.010
114. J Pediatr. 2017 Dec;191:91-95.e1. doi: 10.1016/j.jpeds.2017.08.039. Epub 2017 Oct

13.
Salivary Cortisol Levels Predict Therapeutic Response to a Sleep-Promoting Method

in Children with Postural Tachycardia Syndrome.
Lin J(1), Zhao H(2), Shen J(3), Jiao F(4).
Author information:
(1)Department of Child and Adolescent Health Science Center, School of Public
Health, Xi'an Jiaotong University, Xi'an, Shaanxi, China. Electronic address:
linjkaoyan2008@163.com.
(2)Department of Urology, the Third Affiliated Hospital of Medical College, Xi'an
Jiaotong University, Xi'an, China.
(3)Department of Cardiology, Children's Hospital, Zhejiang University School of
Medicine, Hangzhou, China.
(4)Department of Pediatrics, The Third Affiliated Hospital of Medical College,
Xi'an Jiaotong University, Xi'an, China.
OBJECTIVE: To determine the value of salivary cortisol concentrations in

predicting the efficacy of sleep-promoting treatment in children with postural
tachycardia syndrome (POTS).
STUDY DESIGN: This prospective study involved 40 children with POTS and 20
healthy children (controls). POTS was diagnosed using the head-up or head-up tilt
test. Patients with POTS received a sleep-promoting treatment: >8 hours of sleep
every night and a midday nap in an appropriate environment; no drinking water or
exercising before bedtime; and urination before bedtime. The Pittsburgh Sleep
Quality Index was used to evaluate sleep quality, and symptom scores were used to
assess POTS severity. Salivary samples were collected upon awakening, 30 minutes
after awakening, at 12:00 p.m., 4:00 p.m., and 8:00 p.m., and at bedtime before
treatment. Enzyme-linked immunosorbent assay was used to measure salivary
cortisol concentrations.
RESULTS: Cortisol concentrations were significantly higher in patients with POTS
than in the controls at all time points (P < .05 for all). PSQI scores were
significantly higher in patients with POTS (7.2 ± 3.0) than in the controls
(1.35 ± 1.39; t = -10.370, P <.001). Salivary cortisol concentrations at
awakening were significantly higher in responders than in nonresponders
(4.83 ± 0.73 vs 4.05 ± 0.79 ng/mL, t = -3.197, P = .003). The area under the
receiver operating characteristic curve was 75.8%, (95% CI 59.3%-92%). Cut-off
at-awakening salivary cortisol concentrations of >4.1 ng/mL yielded 83.3%
sensitivity and 68.7% specificity in predicting therapeutic efficacy.
CONCLUSIONS: At-awakening salivary cortisol concentrations may predict the
efficacy of sleep-promoting treatment in patients with POTS.
Copyright © 2017 Elsevier Inc. All rights reserved.
DOI: 10.1016/j.jpeds.2017.08.039
115. Chronobiol Int. 2015;32(8):1049-60. doi: 10.3109/07420528.2015.1056304.
Can sleep quality and wellbeing be improved by changing the indoor lighting in
the homes of healthy, elderly citizens?
Sander B(1), Markvart J(2), Kessel L(1), Argyraki A(3), Johnsen K(2).
Author information:
(1)a Department of Ophthalmology , Rigshospitalet - Glostrup, University of
Copenhagen , Glostrup , Denmark .
(2)b Department of Energy and Environment , Danish Building Research Institute,
Aalborg University Copenhagen , Denmark , and.
(3)c Department of Photonics Engineering , Technical University of Denmark ,
Roskilde , Denmark.
The study investigated the effect of bright blue-enriched versus blue-suppressed

indoor light on sleep and wellbeing of healthy participants over 65 years.
Twenty-nine participants in 20 private houses in a uniform settlement in
Copenhagen were exposed to two light epochs of 3 weeks with blue-enriched (280
lux) and 3 weeks blue-suppressed (240 lux) indoor light or vice versa from 8 to
13 pm in a randomized cross-over design. The first light epoch was in October,
the second in November and the two light epochs were separated by one week.
Participants were examined at baseline and at the end of each light epoch. The
experimental indoor light was well tolerated by the majority of the participants.
Sleep duration was 7.44 (95% CI 7.14-7.74) hours during blue-enriched conditions
and 7.31 (95% CI 7.01-7.62) hours during blue-suppressed conditions (p = 0.289).
Neither rest hours, chromatic pupillometry, nor saliva melatonin profile showed
significant changes between blue-enriched and blue-suppressed epochs. Baseline
Pittsburgh Sleep Quality Index (PSQI) was significantly worse in females; 7.62
(95% CI 5.13-10.0) versus 4.06 (95% CI 2.64-5.49) in males, p = 0.009. For
females, PSQI improved significantly during blue-enriched light exposure (p =
0.007); no significant changes were found for males. The subjective grading of
indoor light quality doubled from participants habitual indoor light to the
bright experimental light, while it was stable between light epochs, although
there were clear differences between blue-enriched and blue-suppressed electrical
light conditions imposed. Even though the study was carried out in the late
autumn at northern latitude, the only significant difference in
Actiwatch-measured total blue light exposure was from 8 to 9 am, because
contributions from blue-enriched, bright indoor light were superseded by
contributions from daylight.
DOI: 10.3109/07420528.2015.1056304
PMCID: PMC4673571
116. J Stroke Cerebrovasc Dis. 2019 Aug;28(8):2115-2123. doi:

10.1016/j.jstrokecerebrovasdis.2019.04.010. Epub 2019 May 23.
Examining the Inter-relations of Depression, Physical Function, and Cognition

with Subjective Sleep Parameters among Stroke Survivors: A Cross-sectional
Analysis.
Davis JC(1), Falck RS(2), Best JR(2), Chan P(3), Doherty S(3), Liu-Ambrose T(2).
Author information:
(1)Faculty of Management, University of British Columbia, Okanagan, Kelowna,
British Columbia, Canada; Aging, Mobility, and Cognitive Neuroscience Lab,
Department of Physical Therapy, University of British Columbia, Vancouver,
British Columbia, Canada; Center for Hip Health and Mobility, Vancouver Coastal
Health Research Institute, Vancouver, British Columbia, Canada. Electronic
address: jennifer.davis@ubc.ca.
(2)Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical
Therapy, University of British Columbia, Vancouver, British Columbia, Canada;
Center for Hip Health and Mobility, Vancouver Coastal Health Research Institute,
Vancouver, British Columbia, Canada; Djavad Mowafaghian Centre for Brain Health,
Vancouver, British Columbia; Department of Physical Therapy, University of
British Columbia, Vancouver, British Columbia, Canada.
(3)Center for Hip Health and Mobility, Vancouver Coastal Health Research
Institute, Vancouver, British Columbia, Canada; Djavad Mowafaghian Centre for
Brain Health, Vancouver, British Columbia.
GOAL: Stroke survivors commonly experience depression as well as deficits in

physical and cognition function. Emerging evidence also suggests sleep quality is
compromised poststroke. Our primary objective was to examine the association of
subjective sleep parameters (ie, total PSQI score) with depression, health
related quality of life, physical function, and cognition among stroke survivors.
MATERIALS AND METHODS: Cross-sectional analysis of 72 older adults with chronic
stroke (≥6 months postischemic stroke) enrolled in a randomized controlled trial
of exercise or cognitive enrichment. Subjective sleep parameters were assessed
using the Pittsburgh Sleep Quality Index (PSQI). We report total PSQI score and
specific PSQI parameter scores (ie, PSQI-subjective sleep quality, PSQI-sleep
latency, PSQI-sleep duration, PSQI-habitual sleep efficiency, PSQI-sleep
disturbances, PSQI-use of sleep medication, and PSQI-daytime dysfunction).
Bivariate correlations and multivariate linear regression assessed associations
between subjective sleep parameters and depression/health related quality of
life, physical function, and cognition.
FINDINGS: For bivariate correlations, depression was significantly associated
with global PSQI, PSQI-subjective sleep quality, PSQI-habitual sleep efficiency,
and PSQI-daytime dysfunction. Health related quality of life was significantly
associated with PSQI-sleep medication. Physical function and health was
significantly associated with PSQI-subjective sleep quality, PSQI-sleep latency,
PSQI-sleep duration, and PSQI-daytime dysfunction. Multivariate linear regression
demonstrated that PSQI-daytime dysfunction predicted depression and physical
function; PSQI-subjective sleep quality predicted depression. No significant
associations between global PSQI subjective sleep parameters with cognition were
observed.
CONCLUSION: Poor subjective sleep parameters and PSQI-subjective sleep quality
among stroke survivors were associated with depression; PSQI-daytime dysfunction
was associated with physical function. Thus, sleep should be considered in the
management of those who have suffered a stroke to optimize poststroke
rehabilitation outcomes.
DOI: 10.1016/j.jstrokecerebrovasdis.2019.04.010
117. J Med Internet Res. 2018 Dec 7;20(12):e10124. doi: 10.2196/10124.
Clinical Feasibility of a Just-in-Time Adaptive Intervention App (iREST) as a

Behavioral Sleep Treatment in a Military Population: Feasibility Comparative
Effectiveness Study.
Pulantara IW(1), Parmanto B(1), Germain A(2).
Author information:
(1)Health and Rehabilitation Informatics Laboratory, Department of Health
Information Management, University of Pittsburgh, Pittsburgh, PA, United States.
(2)Sleep and Behavioral Neuroscience Center, Department of Psychiatry, University
of Pittsburgh, Pittsburgh, PA, United States.
BACKGROUND: Although evidence-based cognitive behavioral sleep treatments have

been shown to be safe and effective, these treatments have limited scalability.
Mobile health tools can address this scalability challenge. iREST, or interactive
Resilience Enhancing Sleep Tactics, is a mobile health platform designed to
provide a just-in-time adaptive intervention (JITAI) in the assessment,
monitoring, and delivery of evidence-based sleep recommendations in a scalable
and personalized manner. The platform includes a mobile phone-based patient app
linked to a clinician portal.
OBJECTIVE: The first aim of the pilot study was to evaluate the effectiveness of
JITAI using the iREST platform for delivering evidence-based sleep interventions
in a sample of military service members and veterans. The second aim was to
explore the potential effectiveness of this treatment delivery form relative to
habitual in-person delivery.
METHODS: In this pilot study, military service members and veterans between the
ages of 18 and 60 years who reported clinically significant service-related sleep
disturbances were enrolled as participants. Participants were asked to use iREST
for a period of 4 to 6 weeks during which time they completed a daily sleep/wake
diary. Through the clinician portal, trained clinicians offered recommendations
consistent with evidence-based behavioral sleep treatments on weeks 2 through 4.
To explore potential effectiveness, self-report measures were used, including the
Insomnia Severity Index (ISI), the Pittsburgh Sleep Quality Index (PSQI), and the
PSQI Addendum for Posttraumatic Stress Disorder.
RESULTS: A total of 27 participants completed the posttreatment assessments.
Between pre- and postintervention, clinically and statistically significant
improvements in primary and secondary outcomes were detected (eg, a mean
reduction on the ISI of 9.96, t26=9.99, P<.001). At posttreatment, 70% (19/27) of
participants met the criteria for treatment response and 59% (16/27) achieved
remission. Comparing these response and remission rates with previously published
results for in-person trials showed no significant differences.
CONCLUSION: Participants who received evidence-based recommendations from their
assigned clinicians through the iREST platform showed clinically significant
improvements in insomnia severity, overall sleep quality, and disruptive
nocturnal disturbances. These findings are promising, and a larger noninferiority
clinical trial is warranted.
©I Wayan Pulantara, Bambang Parmanto, Anne Germain. Originally published in the

Journal of Medical Internet Research (http://www.jmir.org), 07.12.2018.
DOI: 10.2196/10124
PMCID: PMC6303679
118. Lancet. 2015 Dec 12;386(10011):2404-12. doi: 10.1016/S0140-6736(15)00308-6. Epub

2015 Sep 27.
Efficacy, safety, and tolerability of augmentation pharmacotherapy with

aripiprazole for treatment-resistant depression in late life: a randomised,
double-blind, placebo-controlled trial.
Lenze EJ(1), Mulsant BH(2), Blumberger DM(2), Karp JF(3), Newcomer JW(4),
Anderson SJ(5), Dew MA(3), Butters MA(3), Stack JA(3), Begley AE(3), Reynolds CF
3rd(6).
Author information:
(1)Washington University School of Medicine, St Louis, MO, USA. Electronic
address: lenzee@psychiatry.wustl.edu.
(2)Centre for Addiction and Mental Health and Department of Psychiatry,
University of Toronto, Toronto, ON, Canada.
(3)University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
(4)Charles E Schmidt College of Medicine, Florida Atlantic University, Boca
Raton, FL, USA.
(5)University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA,
USA.
(6)University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; University
of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.
Erratum in
Lancet. 2015 Dec 12;386(10011):2394.
Comment in
Lancet. 2015 Dec 12;386(10011):2374-5.
Ann Intern Med. 2016 Jan 19;164(2):JC10.
BACKGROUND: Treatment-resistant major depression is common and potentially

life-threatening in elderly people, in whom little is known about the benefits
and risks of augmentation pharmacotherapy. We aimed to assess whether
aripiprazole is associated with a higher probability of remission than is
placebo.
METHODS: We did a randomised, double-blind, placebo-controlled trial at three
centres in the USA and Canada to test the efficacy and safety of aripiprazole
augmentation for adults aged older than 60 years with treatment-resistant
depression (Montgomery Asberg Depression Rating Scale [MADRS] score of ≥15).
Patients who did not achieve remission during a pre-trial with venlafaxine
extended-release (150-300 mg/day) were randomly assigned (1:1) to the addition of
aripiprazole (target dose 10 mg [maximum 15 mg] daily) daily or placebo for 12
weeks. The computer-generated randomisation was done in blocks and stratified by
site. Only the database administrator and research pharmacists had knowledge of
treatment assignment. The primary endpoint was remission, defined as an MADRS
score of 10 or less (and at least 2 points below the score at the start of the
randomised phase) at both of the final two consecutive visits, analysed by
intention to treat. This trial is registered with ClinicalTrials.gov, number
NCT00892047.
FINDINGS: From July 20, 2009, to Dec 30, 2013, we recruited 468 eligible
participants, 181 (39%) of whom did not remit and were randomly assigned to
aripiprazole (n=91) or placebo (n=90). A greater proportion of participants in
the aripiprazole group achieved remission than did those in the placebo group (40
[44%] vs 26 [29%] participants; odds ratio [OR] 2·0 [95% CI 1·1-3·7], p=0·03;
number needed to treat [NNT] 6·6 [95% CI 3·5-81·8]). Akathisia was the most
common adverse effect of aripiprazole (reported in 24 [26%] of 91 participants on
aripiprazole vs 11 [12%] of 90 on placebo). Compared with placebo, aripiprazole
was also associated with more Parkinsonism (15 [17%] of 86 vs two [2%] of 81
participants), but not with treatment-emergent suicidal ideation (13 [21%] of 61
vs 19 [29%] of 65 participants) or other measured safety variables.
INTERPRETATION: In adults aged 60 years or older who do not achieve remission
from depression with a first-line antidepressant, the addition of aripiprazole is
effective in achieving and sustaining remission. Tolerability concerns include
the potential for akathisia and Parkinsonism.
FUNDING: National Institute of Mental Health, UPMC Endowment in Geriatric
Psychiatry, Taylor Family Institute for Innovative Psychiatric Research, National
Center for Advancing Translational Sciences, and the Campbell Family Mental
Health Research Institute.
Copyright © 2015 Elsevier Ltd. All rights reserved.
DOI: 10.1016/S0140-6736(15)00308-6
PMCID: PMC4690746
119. J Ethnopharmacol. 2018 Mar 25;214:22-28. doi: 10.1016/j.jep.2017.11.036. Epub

2017 Dec 5.
Efficacy of Violet oil, a traditional Iranian formula, in patients with chronic

insomnia: A randomized, double-blind, placebo-controlled study.
Feyzabadi Z(1), Rezaeitalab F(2), Badiee S(3), Taghipour A(4), Moharari F(5),
Soltanifar A(6), Ahmadpour MR(7).
Author information:
(1)Department of Persian Medicine, School of Persian and Complementary Medicine,
Mashhad University of Medical Sciences, Mashhad, Iran.
(2)Department of Neurology, Faculty of Medicine, Mashhad University of Medical
Sciences, Mashhad, Iran.
(3)Department of Complementary and Chinese Medicine, School of Persian and
Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
(4)Department of Epidemiology & Biostatistics, Management & Social Determinants
of Health Research Center, Cancer Research Center, School of Health, Mashhad
University of Medical Sciences, Mashhad, Iran.
(5)Psychiatry and Behavioral Sciences Research Center, Mashhad University of
Medical Sciences, Mashhad, Iran.
(6)Psychiatry and Behavioral Sciences Research Center, Ibn-E-Sina Hospital,
Department of Psychiatry, Faculty of Medicine, Mashhad University of Medical
Sciences, Mashhad, Iran.
(7)Students Research Committee, Department of Persian Medicine, School of Persian
and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad,
Iran. Electronic address: Drmragp@yahoo.com.
ETHNOPHARMACOLOGICAL RELEVANCE: Violet oil is an ancient herbal drug which has

been extensively used to treat insomnia in traditional Iranian Medicine clinics.
Violet oil is an almond or sesame oil-based extract of Viola odorata, which is
administered as nasal drops. This study aimed to evaluate the efficacy of Violet
oil in the treatment of insomnia.
METHODS AND MATERIALS: This study was conducted as a 3-arm double-blind
randomized trial. A total of 75 patients with chronic insomnia were enrolled and
randomly assigned to three groups in Traditional Iranian Medicine Clinic of
Mashhad University of Medical Sciences, Mashhad, Iran. The treatment consisted of
intranasal dropping of Violet oil, Almond oil or placebo (1% solution of
Carboxymethyl cellulose) in each nostril every night before sleep for 30 days,
i.e. three drops of the drug (including either Violet oil or Almond oil) or the
placebo was used every night before the sleep. All the patients were asked to
complete Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI)
questionnaires before and after the intervention.
RESULTS: There were no significant differences between patients in the three
groups before the intervention (P > 0.05). However, there were significant
differences between the three groups after the intervention in ISI scores
(P<0.002) and PSQI scores (p<0.001). When comparing the pre- and post-treatment
data, the ISI and PSQI scores improved significantly in all the three groups as
follows: Violet oil (P<0.001), Almond oil (P<0.001) and placebo (P<0.001). The
results also showed that the Violet oil had the most effect among the three
groups. In addition, it was more effective on sleep quality than sleep quantity.
CONCLUSION: Considering the effects of natural nasal drug on the improvement of
sleep quality in insomniac patients, this study has proposed the use of Violet
oil as a natural and herbal drug in a non-oral method without serious side
effects for treatment of insomnia.
Copyright © 2017 Elsevier B.V. All rights reserved.
DOI: 10.1016/j.jep.2017.11.036
120. Sleep Med. 2018 Dec;52:180-187. doi: 10.1016/j.sleep.2018.05.011. Epub 2018 May
24.
Joint effect of less than 1 h of daytime napping and seven to 8 h of night sleep
on the risk of stroke.
Li X(1), Pang X(2), Liu Z(2), Zhang Q(2), Sun C(2), Yang J(3), Li Y(4).
Author information:
(1)College of Public Health, Shanghai Jiao Tong University School of Medicine,
Shanghai, 200025, China.
(2)Department of Nutrition and Food Hygiene, College of Public Health, Harbin
Medical University, Harbin, 150081, China.
(3)The School of Public Health & Management, Ningxia Medical University, Ningxia,
China. Electronic address: Yangjj@nxmu.edu.cn.
(4)Department of Nutrition and Food Hygiene, College of Public Health, Harbin
Medical University, Harbin, 150081, China. Electronic address:
liying_helen@163.com.
BACKGROUND: The joint effect of daytime naps and night sleep on the risk of
stroke has not been clarified. Our research aimed to verify this relationship
based on data from a large sample-sized cross-sectional study and a cohort study.
METHODS: The cross-sectional study included 7887 subjects, aged 20-74 years.
Using stratified random sampling, 1928 individuals were selected for the cohort
study. We then followed up with these individuals for an average of 4.94 years
and collected detailed sleep information with the Pittsburgh Sleep Quality Index
(PSQI). Serum fasting blood glucose, triglyceride, cholesterol and high density
lipoprotein were analyzed, and anthropometric measurements were taken.
Interaction and joint analyses were performed.
RESULTS: Consistent with the results in the cross-sectional study, hazard ratios
(HRs) (95% CI) of stroke were 1.94 (1.21-3.13) and 2.24 (1.05-4.79) for daytime
napping ≥1 h and nighttime sleeping ≥9 h in the cohort study. For no naps
combined with <7 h of nighttime sleeping, the HR (95%CI) was 2.61 (1.17-5.82).
For ≥1 h of naps combined with <7 h, 7-8 h, 8-9 h, and ≥9 h of nighttime
sleeping, HRs (95% CI) were 2.16 (1.03-4.51), 2.36 (1.07-5.20), 2.41 (1.11-5.20)
and 3.37 (1.05-10.81), respectively.
CONCLUSIONS: Individuals with 7-8 h of night sleep combined with no daytime naps
or less than 1 h of daytime napping were at low risk of stroke; nighttime
sleeping ≥9 h combined with daytime napping ≥1 h and night sleep <7 h combined
with 0 or >1 h daytime napping was associated with high risk of stroke. CLINICAL
TRIAL REGISTRY: http://www.chictr.org.
TRAIL NUMBER: ChiCTR-ECH-1200272, ChiCTR-ECH-12002938.
Copyright © 2018. Published by Elsevier B.V.
DOI: 10.1016/j.sleep.2018.05.011
121. Intern Med. 2015;54(6):559-65. doi: 10.2169/internalmedicine.54.3718. Epub 2015

Jan 15.
Effects of esomeprazole on sleep in patients with gastroesophageal reflux disease

as assessed on actigraphy.
Hiramoto K(1), Fujiwara Y, Ochi M, Okuyama M, Tanigawa T, Yamagami H, Shiba M,

Watanabe K, Watanabe T, Tominaga K, Arakawa T.
Author information:
(1)Department of Gastroenterology, Osaka City University Graduate School of
Medicine, Japan.
OBJECTIVE: Gastroesophageal reflux disease (GERD) is strongly associated with

sleep disturbances. Although treatment with proton pump inhibitors (PPIs) helps
to improve GERD symptoms and subjective sleep parameters, the effects of PPI
therapy on objective sleep parameters are conflicting. The aim of this study was
to examine the effects of esomeprazole treatment on GERD symptoms and sleep
parameters assessed using actigraphs and questionnaires.
METHODS: Thirteen patients with GERD received 20 mg of esomeprazole once daily
for two weeks. The patients wore actigraphs from three days before the initiation
of PPI treatment to the end of therapy. They were also asked to answer the
following self-reported questionnaires: Frequency Scale for the Symptoms of GERD
(FSSG), Pittsburg Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS).
Objective sleep parameters were evaluated using actigraphy.
RESULTS: Treatment with esomeprazole significantly decreased the total FSSG
score, including the scores for reflux and dysmotility, as well as the ESS score,
although it had no effect on the PSQI score. After the second week of treatment,
esomeprazole significantly decreased the wake time (from 47.5±39.6 min to
36.0±27.1 min) and sleep latency period (from 19.5±19.8 min to 9.9±10.2 min) and
increased the percentage of sleep time (from 89.1±8.8% to 91.9±6.3%); however,
improvements were not noted in all objective parameters.
CONCLUSION: Esomeprazole treatment significantly improves various objective sleep
parameters in Japanese patients with GERD. Further placebo-controlled randomized
trials are needed to obtain detailed results.
DOI: 10.2169/internalmedicine.54.3718
122. J Child Psychol Psychiatry. 2018 Jun;59(6):637-649. doi: 10.1111/jcpp.12842. Epub

2017 Nov 22.
Who benefits from adolescent sleep interventions? Moderators of treatment

efficacy in a randomized controlled trial of a cognitive-behavioral and
mindfulness-based group sleep intervention for at-risk adolescents.
Blake MJ(1), Blake LM(1), Schwartz O(1), Raniti M(1), Waloszek JM(1), Murray
G(2), Simmons JG(3), Landau E(1), Dahl RE(4), McMakin DL(5)(6), Dudgeon P(1),
Trinder J(1), Allen NB(1)(7).
Author information:
(1)Melbourne School of Psychological Sciences, The University of Melbourne,
Melbourne, Vic., Australia.
(2)Department Psychological Sciences, Swinburne University of Technology,
Hawthorn, Vic., Australia.
(3)Department of Psychiatry, The University of Melbourne, Melbourne, Vic.,
Australia.
(4)School of Public Health, University of California, Berkeley, Berkeley, CA,
USA.
(5)Department of Psychology, Florida International University, Miami, FL, USA.
(6)Psychology Division, Nicklaus Children's Hospital, Miami, FL, USA.
(7)Department of Psychology, University of Oregon, Eugene, OR, USA.
BACKGROUND: The aim of this study was to test moderators of therapeutic
improvement in an adolescent cognitive-behavioral and mindfulness-based group
sleep intervention. Specifically, we examined whether the effects of the program
on postintervention sleep outcomes were dependent on participant gender and/or
measures of sleep duration, anxiety, depression, and self-efficacy prior to the
interventions.
METHOD: Secondary analysis of a randomized controlled trial conducted with 123
adolescent participants (female = 59.34%; mean age = 14.48 years, range
12.04-16.31 years) who had elevated levels of sleep problems and anxiety
symptoms. Participants were randomized into either a group sleep improvement
intervention (n = 63) or group active control 'study skills' intervention
(n = 60). The sleep intervention ('Sleep SENSE') was cognitive behavioral in
approach, incorporating sleep education, sleep hygiene, stimulus control, and
cognitive restructuring, but also had added anxiety-reducing, mindfulness, and
motivational interviewing elements. Components of the active control intervention
('Study SENSE') included personal organization, persuasive writing, critical
reading, referencing, memorization, and note taking. Participants completed the
Pittsburgh Sleep Quality Index (PSQI), Spence Children's Anxiety Scale (SCAS),
Center for Epidemiologic Studies Depression Scale (CES-D), and General
Self-Efficacy Scale (GSE) and wore an actigraph and completed a sleep diary for
five school nights prior to the interventions. Sleep assessments were repeated at
postintervention. The trial is registered with the Australian New Zealand
Clinical Trials Registry (ACTRN12612001177842;
http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12612001177842&isBasic=T
rue).
RESULTS: The results showed that compared with the active control intervention,
the effect of the sleep intervention on self-reported sleep quality (PSQI global
score) at postintervention was statistically significant among adolescents with
relatively moderate to high SCAS, CES-D, and GSE prior to the intervention, but
not among adolescents with relatively low SCAS, CES-D, and GSE prior to the
intervention. The results were consistent across genders. However, the effects of
the sleep intervention on actigraphy-measured sleep onset latency and sleep
diary-measured sleep efficiency at postintervention were not dependent on
actigraphy-measured total sleep time, SCAS, CES-D, or GSE prior to the
intervention.
CONCLUSIONS: This study provides evidence that some sleep benefits of adolescent
cognitive-behavioral sleep interventions are greatest among those with higher
levels of anxiety and depressive symptoms, suggesting that this may be an
especially propitious group to whom intervention efforts could be targeted.
Furthermore, adolescents with lower levels of self-efficacy may need further
targeted support (e.g. additional motivational interviewing) to help them reach
treatment goals.
© 2017 Association for Child and Adolescent Mental Health.
DOI: 10.1111/jcpp.12842
123. J Biol Regul Homeost Agents. 2017 Jul-Sep;31(3):745-751.
Sleep disorders of acute thalamic stroke and its influence on plasma IL-17.
Li Q(1), Zhao X(2), Gong DH(3), Geng YM(4), Zhang HL(4), Bi PX(5).
Author information:
(1)School of Basic Medicine, Mudanjiang Medical University, Mu Danjiang, China
(2)Community, Mudanjiang Medical University, Mu Danjiang, China
(3)Nursing Department, Mudanjiang Medical University, Mu Danjiang, China
(4)School of Public Health, Mudanjiang Medical University, Mu Danjiang, China
(5)Neurology, Mudanjiang Medical University, Mu Danjiang, China
The aim of this study was to investigate the relationship between sleep disorders
in acute thalamus stroke patients and plasma IL-17 levels and the mechanism
through which inflammatory reactions develop in stroke. The study included two
groups of patients: an experimental group consisting of 30 patients with thalamus
stroke who received treatment at the Affiliated Hong Qi Hospital of Mu Dan Jiang
Medical University during October 2015 to October 2016 and a control group
consisting of 15 healthy volunteers. All the subjects included in the study were
biochemically monitored for blood glucose, blood fats and IL-17 plasma levels.
The sleep quality of all the subjects included in the study was evaluated
[Epwort, Pittsburgh Sleep Quality Index (PSQI)] with 8-hour Polysonmography (PSG)
monitoring. The experimental group was divided into 3 subgroups according to the
part of the brain affected by stroke: anterior thalamus nucleus group, lateral
thalamus nucleus group and medial thalamus nucleus group. The differences were
analyzed between the experimental group and the control group in sleep quality
scores, sleep structural changes, and plasma IL-17 levels. The differences in
sleep structural scores were also analyzed according to different parts of the
brain affected by stroke. The experimental group had a higher PSQI score compared
with the control group, but this difference had no statistical significance
(p>0.05). Compared with the control group, the N1 phase of the experimental group
was longer while the N2 and N3 phases were shorter (p<0.05). There were no
differences in sleep structure between the three regions of the brain affected by
stroke (anterior thalamus nucleus group, lateral thalamus nucleus group and
medial thalamus nucleus group) (p > 0.05). The plasma levels of IL-17 in the
experimental group was higher compared to the control group (p<0.05). In the
experimental group, the patients with hypersomnia had higher IL-17 levels than
patients without hypersomnia (p<0.01). We can conclude that PSG can be used as an
electrophysiology index for early detection of sleep disorders in thalamus stroke
patients. Sleep disorders in patients with thalamus stroke persist a long time
after the incident, therefore monitoring their sleep structure may become an
important index to predict the prognosis of the disease. The increased level of
IL-17 level in the experimental group shows its implication in appearance of
sleep disorders of acute thalamus stroke through inflammatory mechanism.
124. J Investig Allergol Clin Immunol. 2018 Dec;28(6):392-400. doi:

10.18176/jiaci.0263. Epub 2018 Apr 24.
Comparative Effect of Beclomethasone Dipropionate and Cetirizine on Acoustic

Rhinometry Parameters in Children With Perennial Allergic Rhinitis: A Randomized
Controlled Trial.
Malizia V(1), Fasola S(1)(2), Ferrante G(3), Cilluffo G(1)(2), Gagliardo R(1),
Landi M(1)(4), Montalbano L(1)(5), Marchese D(1), La Grutta S(1)(3).
Author information:
(1)National Research Council of Italy, Institute of Biomedicine and Molecular
Immunology, Palermo, Italy.
(2)Department of Economics, Business and Statistical Science, University of
Palermo, Italy.
(3)Department of Science for Health Promotion and Mother and Child Care,
University of Palermo, Italy.
(4)National Healthcare System, ASL TO3, Turin, Italy.
(5)Department of Psychology, University of Palermo, Italy.
BACKGROUND AND OBJECTIVES: The effect of intranasal corticosteroids and oral

antihistamines on acoustic rhinometry parameters has not been directly compared.
The primary objective was to compare the effect of a 21-day course of treatment
with nasal beclomethasone dipropionate (nBDP) with that of cetirizine (CTZ) on
nasal patency measured using acoustic rhinometry in children with perennial
allergic rhinitis (PAR). The secondary objective was to compare the effect of
both drugs on nasal cytology, symptom severity, sleep quality, and quality of
life.
METHODS: In this 21-day, open-label, randomized controlled study, 34 children
with PAR (age 6-14 years) with a Total 5-Symptom Score (T5SS) ≥5 received nBDP
100 μg per nostril twice daily or CTZ 10 mg tablets once daily. The measures of
effect were the least square mean change (LSmc) in nasal volume, minimal
cross-sectional area (MCA), and nasal cytology, as well as the scores on the
T5SS, Pittsburgh Sleep Quality Index (PSQI), and Paediatric Rhinoconjunctivitis
Quality of Life Questionnaire (PRQLQ).
RESULTS: After 21 days, nBDP improved nasal volume and MCA more than CTZ (LSmc,
2.21 cm3 vs 0.20 cm3 [P=.013]; and LSmc 0.63 cm2 vs 0.13 cm2 [P=.002],
respectively). Compared with the CTZ group, a more marked improvement was found
in the nBDP group with respect to eosinophil classes (LSmc, -1.10 vs -0.40;
P=.031) and neutrophil classes (LSmc, -0.97 vs -0.17; P=.010), T5SS (LSmc, -5.63
vs -3.54; P=.008), PSQI (LSmc, -1.30 vs -0.19; P=.025), and PRQLQ total scores
(LSmc, -1.15 vs -0.69; P=.031).
CONCLUSIONS: In children with PAR, nBDP is more effective than CTZ in improving
nasal patency measured by acoustic rhinometry, with associated beneficial effects
on nasal cytology, symptoms, sleep quality, and quality of life.
DOI: 10.18176/jiaci.0263
125. Sleep Med. 2016 May;21:140-4. doi: 10.1016/j.sleep.2016.01.016. Epub 2016 Feb 17.
Rotigotine may improve sleep architecture in Parkinson's disease: a double-blind,

randomized, placebo-controlled polysomnographic study.
Pierantozzi M(1), Placidi F(2), Liguori C(3), Albanese M(4), Imbriani P(1),
Marciani MG(4), Mercuri NB(5), Stanzione P(6), Stefani A(7).
Author information:
(1)Movement Disorders Centre, Department of Systems Medicine, University of Rome
"Tor Vergata", Rome, Italy.
(2)Sleep Disorders Centre, Neurophysiopathology Unit, Department of Systems
Medicine, University of Rome "Tor Vergata", Rome, Italy.
Medicine, University of Rome "Tor Vergata", Rome, Italy. Electronic address:
dott.claudioliguori@yahoo.it.
(4)Neurology Unit, Department of Systems Medicine, University of Rome "Tor
Vergata", Rome, Italy.
Medicine, University of Rome "Tor Vergata", Rome, Italy; Neurology Unit,
Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy;
IRCCS Santa Lucia Foundation, Rome, Italy.
"Tor Vergata", Rome, Italy; Sleep Disorders Centre, Neurophysiopathology Unit,
Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy;
IRCCS Santa Lucia Foundation, Rome, Italy.
"Tor Vergata", Rome, Italy; IRCCS Santa Lucia Foundation, Rome, Italy.
BACKGROUND/OBJECTIVES: Growing evidence demonstrates that in Parkinson's Disease

(PD) sleep disturbances are frequent and difficult to treat. Since the efficacy
of rotigotine on sleep is corroborated by studies lacking polysomnography (PSG),
this study explores the possible rotigotine-mediated impact on PSG parameters in
PD patients.
METHODS: This is a randomized, double-blind, placebo-controlled, parallel-group
study to determine the efficacy of rotigotine vs placebo on PSG parameters in
moderately advanced PD patients. An unusual protocol was utilized, since patches
were maintained from 18:00 h to awakening, minimizing the possible diurnal impact
on motor symptoms. All participants underwent sleep PSG recordings, subjective
sleep questionnaires (Parkinson Disease Sleep Scale [PDSS], Pittsburgh Sleep
Quality Index [PSQI]), and the assessment of early-morning motor disability.
RESULTS: We evaluated 42 PD patients (Hoehn & Yahr stages 2 and 3) with sleep
impairment randomly assigned to active branch (N =21) or placebo (N = 21).
Rotigotine significantly increased sleep efficiency and reduced both wakefulness
after sleep onset and sleep latency compared to placebo. Moreover, the mean
change in REM sleep quantity was significantly higher in the rotigotine than
placebo group. The improvement of PSG parameters corresponded to the amelioration
of PDSS and PSQI scores together with the improvement of patient morning motor
symptoms.
CONCLUSIONS: This study demonstrated the significant effect of rotigotine on
sleep quality and continuity in PD patients by promoting sleep stability and
increasing REM. The effectiveness of rotigotine on sleep may be ascribed to its
pharmacokinetic/pharmacodynamic profile directly on both D1 and D2 receptors.
DOI: 10.1016/j.sleep.2016.01.016
126. Complement Ther Clin Pract. 2018 May;31:315-319. doi: 10.1016/j.ctcp.2018.02.017.

Epub 2018 Mar 1.
The effects of reflexology on pain and sleep deprivation in patients with

rheumatoid arthritis: A randomized controlled trial.
Bakir E(1), Baglama SS(2), Gursoy S(3).
Author information:
(1)Gaziantep University Health Science Faculty Nursing Department, 27310,
Gaziantep, Turkey. Electronic address: e.bakir02@gmail.com.
(2)Gaziantep University Health Science Faculty Nursing Department, 27310,
Gaziantep, Turkey. Electronic address: sevginsamancioglu@hotmail.com.
(3)Gaziantep University Medical Faculty, Department Of Physical Medicine and
Rehabilitation, 27310, Gaziantep, Turkey. Electronic address:
savasgursoy@gantep.edu.tr.
OBJECTIVE: This study was intended to examine the effect of foot reflexology on
RA patients' pain and sleep quality.
METHODS: This is a randomized controlled trial and was held at the "Rheumatology
Follow-up Polyclinic" in Turkey between January-July 2015. A total of 60 patients
were included in the research. A sociodemographic data form, the Pittsburgh Sleep
Quality Index (PSQI) and the Visual Analogue Scale (VAS) were used. Foot
Reflexology was administered to the experimental group.
RESULTS: The research found that the pain scores of the experimental group were
statistically more significant than those of the control group (p < .01). The
experimental group's average pain was reduced by the six weeks of foot
reflexology. The total PSQI score of the experimental group was lowered.
CONCLUSIONS: Foot reflexology is a non-pharmacological nursing intervention that
may reduce the pain and sleep deprivation symptoms of RA patients.
Copyright © 2018 Elsevier Ltd. All rights reserved.
DOI: 10.1016/j.ctcp.2018.02.017
127. J Gen Intern Med. 2018 Jun;33(6):825-830. doi: 10.1007/s11606-018-4348-3. Epub

2018 Feb 20.
So Tired: Predictive Utility of Baseline Sleep Screening in a Longitudinal

Observational Survey Cohort of First-Year Residents.
Zebrowski JP(1)(2)(3), Pulliam SJ(4), Denninger JW(5)(6)(7), Berkowitz

LR(6)(8)(9).
Author information:
(1)Department of Psychiatry , Massachusetts General Hospital, Boston, MA, USA.
jzebrowski@partners.org.
(2)McLean Hospital, Belmont, MA, USA. jzebrowski@partners.org.
(3)Harvard Medical School, Boston, MA, USA. jzebrowski@partners.org.
(4)Division of Urogynecology and Reconstructive Pelvic Surgery, Department of
Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel
Hill, NC, USA.
(5)Department of Psychiatry , Massachusetts General Hospital, Boston, MA, USA.
(6)Harvard Medical School, Boston, MA, USA.
(7)Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital,
Boston, MA, USA.
(8)Department of Obstetrics, Gynecology, and Reproductive Biology, Massachusetts
General Hospital, Boston, MA, USA.
(9)Office of Graduate Medical Education, Partners Healthcare, Boston, MA, USA.
Comment in
J Gen Intern Med. 2018 Jun;33(6):942.
BACKGROUND: Sleep impairment is highly prevalent among resident physicians and is

associated with both adverse patient outcomes and poor resident mental and
physical health. Risk factors for sleep problems during residency are less clear,
and no screening model exists to identify residents at risk for sleep impairment.
OBJECTIVE: The objective of this study was to assess change in resident sleep
during training and to evaluate utility of baseline sleep screening in predicting
future sleep impairment.
DESIGN: This is a prospective observational repeated-measures survey study.
PARTICIPANTS: The participants comprised PGY-1 residents across multiple
specialties at Partners HealthCare hospitals.
MAIN MEASURES: Main measures used for this study were demographic queries and two
validated scales: the Pittsburgh Sleep Quality Index (PSQI), measuring sleep
quality, and the Epworth Sleepiness Scale (ESS), measuring excessive daytime
sleepiness.
KEY RESULTS: Two hundred eighty-one PGY-1 residents completed surveys at
residency orientation, and 153 (54%) completed matched surveys 9 months later.
Mean nightly sleep time decreased from 7.6 to 6.5 hours (p < 0.001). Mean PSQI
score increased from 3.6 to 5.2 (p < 0.001), and mean ESS score increased from
7.2 to 10.4 (p < 0.001). The proportion of residents exceeding the scales'
clinical cutoffs increased over time from 15 to 40% on the PSQI (p < 0.001) and
from 26 to 59% on the ESS (p < 0.001). Baseline normal sleep was not protective:
68% of residents with normal scores on both scales at baseline exceeded the
clinical cutoff on at least one scale at follow-up. Greater age and fewer
children increased follow-up PSQI score (p < 0.001) but not ESS score.
CONCLUSIONS: During PGY-1 training, residents experience worsening sleep
duration, quality of sleep, and daytime sleepiness. Residents with baseline
impaired sleep tend to remain impaired. Moreover, many residents with baseline
normal sleep experience sleep deterioration over time. Sleep screening at
residency orientation may identify some, but not all, residents who will
experience sleep impairment during training.
DOI: 10.1007/s11606-018-4348-3
PMCID: PMC5975152
128. Neurol Sci. 2016 Jan;37(1):57-65. doi: 10.1007/s10072-015-2357-0. Epub 2015 Aug
9.
Exogenous melatonin for sleep disorders in neurodegenerative diseases: a

meta-analysis of randomized clinical trials.
Zhang W(1), Chen XY(2), Su SW(2), Jia QZ(2), Ding T(3), Zhu ZN(4), Zhang T(5).
Author information:
(1)Capital Medical University School of Rehabilitation Medicine, China
Rehabilitation Research Center, 10, Jiaomenbei Road, FengTai District, Beijing,
100068, China.
(2)Department of Pharmacology, Hebei Medical University, 361, Zhongshan East
Road, Shijiazhuang, 050017, China.
(3)Department of Pathology, School of Basic Medicine, Hebei University of Chinese
Medicine, 3, Xingyuan Road, Luquan, Shijiazhuang, 050200, China.
(4)Department of Pharmacology, Hebei Medical University, 361, Zhongshan East
Road, Shijiazhuang, 050017, China. zzn1970@hotmail.com.
(5)Capital Medical University School of Rehabilitation Medicine, China
Rehabilitation Research Center, 10, Jiaomenbei Road, FengTai District, Beijing,
100068, China. zt61611@sohu.com.
The purpose of this work is to investigate the efficacy of exogenous melatonin in

the treatment of sleep disorders in patients with neurodegenerative disease. We
searched Pubmed, the Cochrane Library, and ClinicalTrials.gov, from inception to
July 2015. We included randomized clinical trials (RCTs) that compared melatonin
with placebo and that had the primary aim of improving sleep in people with
neurodegenerative diseases, particularly Alzheimer's disease (AD) and Parkinson's
disease (PD). We pooled data with the weighted mean difference in sleep outcomes.
To assess heterogeneity in results of individual studies, we used Cochran's Q
statistic and the I (2) statistic. 9 RCTs were included in this research. We
found that the treatment with exogenous melatonin has positive effects on sleep
quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) in PD patients
(MD: 4.20, 95 % CI: 0.92-7.48; P = 0.01), and by changes in PSQI component 4 in
AD patients (MD: 0.67, 95 % CI: 0.04-1.30; P = 0.04), but not on objective sleep
outcomes in both AD and PD patients. Treatment with melatonin effectively
improved the clinical and neurophysiological aspects of rapid eye movement (REM)
sleep behavior disorder (RBD), especially elderly individuals with underlying
neurodegenerative disorders. This meta-analysis provided some evidence that
melatonin improves sleep quality in patients with AD and PD, and melatonin can be
considered as a possible sole or add-on therapy in neurodegenerative disorders
patients with RBD.
DOI: 10.1007/s10072-015-2357-0
129. Sleep Breath. 2017 Mar;21(1):191-195. doi: 10.1007/s11325-017-1462-0. Epub 2017

Jan 18.
Effect and safety of paroxetine combined with zolpidem in treatment of primary

insomnia.
Yu ZH(1), Xu XH(1), Wang SD(2), Song MF(1), Liu Y(1), Yin Y(1), Mao HJ(1), Tang
GZ(1).
Author information:
(1)Hangzhou Seventh People's Hospital, Hangzhou, 310013, China.
(2)Hangzhou Seventh People's Hospital, Hangzhou, 310013, China.
wangsd0108@sina.com.
PURPOSE: Primary insomnia is a persistent and recurrent disorder as well as a

risk factor for depression. The aim of this study was to determine whether the
zolpidem combined with paroxetine would be effective in the treatment of patients
with primary insomnia.
METHODS: Ninety patients meeting DSM-IV criteria for primary insomnia were
randomly assigned to 8 weeks of treatment with zolpidem combined with paroxetine
(the combined treatment group, n = 45) or zolpidem combined with placebo (the
control group, n = 45). Patients were assessed with the Pittsburgh Sleep Quality
Index (PSQI), polysomnography (PSG), and the Treatment Emergent Symptom Scale
(TESS).
RESULTS: Compared with the control group, the combined treatment group was more
significantly improved on wake time after sleep onset (WASO), total sleep time
(TST), sleep efficiency (SE), and total PSQI scores, but not the sleep onset
latency (SOL).
CONCLUSIONS: Eight weeks of the zolpidem combined with paroxetine treatment to
patients with primary insomnia is more effective than zolpidem treatment only in
sleep maintenance and early morning awakenings.
DOI: 10.1007/s11325-017-1462-0
130. J Altern Complement Med. 2016 Jan;22(1):52-8. doi: 10.1089/acm.2015.0018. Epub

2015 Dec 15.
Effects of Ayurvedic Oil-Dripping Treatment with Sesame Oil vs. with Warm Water
on Sleep: A Randomized Single-Blinded Crossover Pilot Study.
Tokinobu A(1)(2), Yorifuji T(2), Tsuda T(2), Doi H(1).
Author information:
(1)1 Department of Epidemiology, Okayama University Graduate School of Medicine ,
Dentistry and Pharmaceutical Sciences, Kita-ku, Okayama, Japan .
(2)2 Department of Human Ecology, Okayama University Graduate School of
Environmental and Life Science , Kita-ku, Okayama, Japan .
OBJECTIVES: Ayurvedic oil-dripping treatment (Shirodhara) is often used for

treating sleep problems. However, few properly designed studies have been
conducted, and the quantitative effect of Shirodhara is unclear. This study
sought to quantitatively evaluate the effect of sesame oil Shirodhara (SOS)
against warm water Shirodhara (WWS) on improving sleep quality and quality of
life (QOL) among persons reporting sleep problems.
METHODS: This randomized, single-blinded, crossover study recruited 20
participants. Each participant received seven 30-minute sessions within 2 weeks
with either liquid. The washout period was at least 2 months. The Shirodhara
procedure was conducted by a robotic oil-drip system. The outcomes were assessed
by the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, Epworth
Sleepiness Scale (ESS) for daytime sleepiness, World Health Organization Quality
of Life 26 (WHO-QOL26) for QOL, and a sleep monitor instrument for objective
sleep measures. Changes between baseline and follow-up periods were compared
between the two types of Shirodhara. Analysis was performed with generalized
estimating equations.
RESULTS: Of 20 participants, 15 completed the study. SOS improved sleep quality,
as measured by PSQI. The SOS score was 1.83 points lower (95% confidence interval
[CI], -3.37 to -0.30) at 2-week follow-up and 1.73 points lower (95% CI, -3.84 to
0.38) than WWS at 6-week follow-up. Although marginally significant, SOS also
improved QOL by 0.22 points at 2-week follow-up and 0.19 points at 6-week
follow-up compared with WWS. After SOS, no beneficial effects were observed on
daytime sleepiness or objective sleep measures.
CONCLUSIONS: This pilot study demonstrated that SOS may be a safe potential
treatment to improve sleep quality and QOL in persons with sleep problems.
DOI: 10.1089/acm.2015.0018
PMCID: PMC4739344
131. Curr Med Sci. 2018 Jun;38(3):491-498. doi: 10.1007/s11596-018-1905-2. Epub 2018
Jun 22.
Effect of Acupuncture Cooperated with Low-frequency Repetitive Transcranial

Magnetic Stimulation on Chronic Insomnia: A Randomized Clinical Trial.
Zhang YP(1)(2), Liao WJ(3), Xia WG(2).
Author information:
(1)Department of Physical Medicine and Rehabilitation, Zhongnan Hospital of Wuhan
University, Wuhan, 430071, China.
(2)Department of Physical Medicine and Rehabilitation, Hubei Provincial Hospital
of Integrated Chinese and Western Medicine, Wuhan, 430015, China.
(3)Department of Physical Medicine and Rehabilitation, Zhongnan Hospital of Wuhan
University, Wuhan, 430071, China. weijingliao@sina.com.
The effect of acupuncture cooperated with low-frequency repetitive transcranial

magnetic stimulation (rTMS) on chronic insomnia was explored. Seventy-eight
patients with chronic insomnia were randomly allocated into two groups: treatment
group and control group. In the treatment group, the patients received
acupuncture combined with rTMS treatment, and those in the control group were
given acupuncture cooperated with sham rTMS treatment, 3 days per week for 4
weeks. Before and after treatment, the primary outcomes including the scores on
Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) and the
secondary outcomes including total sleep time (TST), sleep onset latency (SOL),
wake after sleep onset (WASO), sleep efficiency (SE%) recorded by sleeping diary
and actigraphy were observed in both groups. Seventy-five participants finished
the study (38 in treatment group and 37 in control group respectively). After
treatment, the scores in the two groups were improved significantly, more
significantly in the treatment group than in the control group. It can be
inferred that acupuncture cooperated with rTMS can effectively improve sleep
quality, enhance the quality of life of patients and has less side effects.
DOI: 10.1007/s11596-018-1905-2
132. Zhongguo Zhen Jiu. 2017 Jan 12;37(1):19-23. doi:

10.13703/j.0255-2930.2017.01.004.
[Regulation action and nerve electrophysiology mechanism of acupuncture on

arousal state in patients of primary insomnia].
[Article in Chinese]
Liu Y(1), Feng H(2), Liu W(1), Mao H(1), Mo Y(1), Yin Y(1), Yu Z(1), Xu L(1).
Author information:
(1)Psychology Department, Hangzhou Seventh People's Hospital, Hangzhou 310013,
Zhejiang Province, China.
(2)Hangzhou Red Cross Hospital, Hangzhou Seventh People's Hospital, Hangzhou
310013, Zhejiang Province, China.
OBJECTIVE: To compare the difference between acupuncture and estazolam on arousal

state in patients of primary insomnia, and to explore its nerve electrophysiology
mechanism.
METHODS: Sixty-four patients of primary insomnia were randomized into an
acupuncture group (32 cases) and a medication group (32 cases). After 3 patients
were excluded, 31 cases in the acupuncture group and 30 cases in the medication
group were included. Patients in the acupuncture group were treated with
acupuncture at Sishencong (EX-HN 1), Anmian (Extra), Shenmen (HT 7), Sanyinjiao
(SP 6), Zhaohai (KI 6), Shenmai (BL 62) as main acupoints, combined with
supporting acupoints, once a day, five times per week, continuously for 4 weeks.
Patients in the medication group were treated with oral administration of
estazolam, once a day, continuously for 4 weeks. The Pittsburgh sleep quality
index (PSQI) and mean sleep latency (MSL) of multiple sleep latency test (MSLT)
were compared before and after treatment in the two groups; the polysomnography
(PSG) was applied to monitor the indices regarding sleep structure.
RESULTS: Compared before treatment, PSQI score was reduced after treatment in the
two groups (both P<0.01), which was more significant in the acupuncture group
(P<0.05). Compared before treatment, sleep onset latency (SOL), number of
awakenings (NWAK) and wake after sleep onset (WASO) were reduced, while total
sleep time (TST) and sleep efficiency (SE) were significantly increased in the
two groups after treatment (all P<0.01). Compared before treatment, the
percentage of non-rapid eye movement period 1/2/3 (N1, N2, N3) and the percentage
of rapid eye movement period (REM) to TST were not significantly changed after
treatment in the medication group (all P>0.05). Compared before treatment, the
percentage of N1, N2 to TST was reduced, while the percentage of N3 and REM to
TST was increased after treatment in the acupuncture group (P<0.01). The SOL,
NWAK, WASO, TST, SE were not statistically changed after treatment in each group
(all P>0.05). Compared with the medication group, the percentage of N1 and N2 was
reduced while that of N3 and REM was increased after treatment in the acupuncture
group (all P<0.01). After treatment, MSL of MSLT were obviously decreased in the
two groups (both P<0.01), which were more significant in the acupuncture group
(P<0.05).
CONCLUSIONS: Acupuncture can more effectively improve sleep quality of primary
insomnia than estazolam, and is more beneficial for regulation of hyperarousal
state.
DOI: 10.13703/j.0255-2930.2017.01.004
133. Zhen Ci Yan Jiu. 2018 Aug 25;43(8):516-21. doi: 10.13702/j.1000-0607.170659.
[Clinical Trial of Acupuncture Treatment of Gastroesophageal Reflux Disease

Accompanied with Somnipathy at Acupoints of Governor Vessel at Back Segment].
Li CY(1), Bai XH(1).
Author information:
(1)School of Acupuncture-moxibustion and Tuina, Beijing University of Chinese
Medicine, Beijing 100029, China.
OBJECTIVE: To observe the curative effect of needling stimulation of the back

segment (10 spots below the spinous processes from T 3 to T 12)of the Governor
Vessel in the treatment of gastroesophageal reflux disease(GERD)accompanied with
somnipathy.
METHODS: A total of 58 patients of GERD accompanied with somnipathy were randomly
divided into acupuncture group (n＝28) and medication group (n＝30)according to
random number table method. For patients of the acupuncture group, the spots
below the spinous processes from T 3 to T 12, including acupoints Shenzhu (GV
12), Shendao (GV 11), Lingtai (GV 10), Zhiyang (GV 9), Jinsuo (GV 8), Zhongshu
(GV 7) and non-acupoints (T 4, T 8, T 12) were punctured with filiform needles,
once every other day for 8 weeks. Patients of the medication group were ordered
to take Omeprazole capsules (20 mg/time), twice a day for 8 weeks. The
therapeutic effect was assessed by "Reflux Diagnostic Questionnaire" (RDQ，scores
of symptoms of heartburn, retrosternal pain, acid regurgitation and food
regurgitation, 0－40 points), GERD symptom scale (scores of symptoms of the
digestive system, five-sense organs, cardiovascular system, etc., 0－84 points)
and Pittsburgh Sleep Quality Index (PSQI, scores of sleep quality, fall asleep
time, sleep duration, sleep efficiency, etc., 0－21 points), respectively.
RESULTS: After the treatment, RDQ score, GERD symptom scale score and PSQI score
were significantly decreased in both acupuncture and medication groups compared
with their own pre-treatment(P<0.01), and the decreased scores of RDQ, GERD scale
and PSQI were significantly lower in the acupuncture group than in the medication
group (P<0.01). The cured plus markedly effective rates for RDQ in the two groups
were 43.3% (13/30) and 71.4% (20/28), respectively, and the effective rates of
the medication and acupuncture groups were 56.7% (17/30) and 89.3% (25/28) for
GERD scale, and 60.0% (18/30) and 92.9% (26/28) for PSQI, respectively. The cured
plus markedly effective rate for RDQ, and the effective rates for GERD scale and
PSQI were signi-ficantly higher in the acupuncture group than in the medication
group respectively (P<0.05，P<0.01)．.
CONCLUSION: Acupuncture stimulation of acupoints of Governor Vessel at the back
segment is effective in improving symptoms of GERD patients with somnipathy.
DOI: 10.13702/j.1000-0607.170659
134. Zhongguo Zhen Jiu. 2018 Jun 12;38(6):575-9. doi:

10.13703/j.0255-2930.2018.06.002.
[Effect of auricular intradermal needling combined with erjian (HX6,7i)

bloodletting on sleep quality and neuroendocrine level in patients with
perimenopausal insomnia].
Meng F(1), Gong W(1), Liao Y(1), Xu H(1), Wang X(2).
Author information:
(1)School of Nursing, Yangzhou University, Yangzhou 225001, Jiangsu Province,
China.
(2)School of Nursing, Nanjing University of CM.
OBJECTIVE: To compare the effect differences between auricular intradermal

needling combined with erjian (HX6,7i) bloodletting and oral administration of
western medicine, and to explore the efficacy of neuroendocrine level in patients
with perimenopausal insomnia.
METHODS: Ninety patients were randomized into an observation group and a control
group, 45 cases in each one. In the observation group, auricular intradermal
needling combined with erjian (HX6,7i) bloodletting were adopted alternately in
the two ears. The auricular points were shen (CO10), xin (CO15), gan (CO12),
shenmen (TF4), jiaogan (AH6a), neifenmi (CO18) and erjian (HX6,7i). The treatment
was required once 3 days on the auricular points of one side alternatively. Oral
administration of estazolam (1mg each day) was applied in the control group for 2
courses, 4 weeks as 1 course, once a day. The scores of Pittsburgh sleep quality
index (PSQI), the levels of serum estrogen (E2), 5-hydroxy tryptamine (5-HT) and
norepinephrine (NE) were valuated in the two groups before and after treatment.
RESULTS: After treatment, the total scores of PSQI reduced in the two groups
(both P<0.05), and the improvements of sleeping quality, sleeping time, sleeping
difficulty, daytime dysfunction and the total PSQI score in the observation group
were superior to those in the control group (all P<0.05). There was no
significant difference in serum E2 before and after treatment in the two
groups，and between the two groups after treatment (all P>0.05). After treatment,
5-HT contents increased and NE levels decreased in the two groups (all P<0.05),
with better results in the observation group (both P<0.05). The total effective
rate was 95.6% (43/45) in the observation group, which was higher than 82.2%
(37/45) in the control group (P<0.05).
CONCLUSION: Auricular intradermal needling combined with erjian (HX6,7i)
bloodletting can improve the sleep quality of patients with perimenopausal
insomnia, and adjust the neurotransmitter level, which achieves better effect
than western medication.
DOI: 10.13703/j.0255-2930.2018.06.002
135. Int Arch Allergy Immunol. 2017;174(2):97-103. doi: 10.1159/000481093. Epub 2017
Oct 24.
Efficacy of Buffered Hypertonic Saline Nasal Irrigation for Nasal Symptoms in

Children with Seasonal Allergic Rhinitis: A Randomized Controlled Trial.
Malizia V(1), Fasola S, Ferrante G, Cilluffo G, Montalbano L, Landi M, Marchese

D, Passalacqua G, La Grutta S.
Author information:
(1)National Research Council of Italy, Institute of Biomedicine and Molecular
Immunology, University of Palermo, Palermo, Italy.
BACKGROUND: Saline nasal irrigation is labelled as an add-on treatment in

patients with allergic rhinitis (AR). The primary aim of this study was to
compare the efficacy of 21-day use of buffered hypertonic saline (BHS) versus
normal saline solution (NSS) on reducing nasal symptoms in children with seasonal
AR (SAR). Comparing their efficacy on nasal cytology counts (NCC), quality of
life, and sleep quality was the secondary aim.
METHODS: In this 21-day, open-label, randomized controlled study, 36 SAR children
(aged 6-13 years) with a Total 5 Symptom Score (T5SS) ≥5 received twice-daily BHS
or NSS delivered through a nasal douche. Efficacy measures were least square mean
changes (LSmc) in T5SS, NCC, Paediatric Rhinoconjunctivitis Quality of Life
Questionnaire (PRQLQ), and Pittsburgh Sleep Quality Index (PSQI) scores.
RESULTS: BHS improved the T5SS total score to a greater extent than NSS (LSmc
-6.45 vs. -5.45, p < 0.001). Concerning NCC, BHS significantly reduced the scores
of neutrophils (LSmc -0.76, p = 0.004) and eosinophils (LSmc -0.46, p = 0.018),
while NSS did not. Similarly, only BHS yielded a significant improvement in the
PRQLQ score (LSmc -0.57, p = 0.009), whereas the improvement in PSQI score was
comparable between the BHS (LSmc -0.77, p = 0.025) and NSS (LSmc -1.39, p <
0.001) groups. Overall, BHS was well tolerated.
CONCLUSIONS: In children with SAR, BHS is effective in improving nasal symptoms
and NCC, with an associated beneficial effect on quality of life.
© 2017 S. Karger AG, Basel.
DOI: 10.1159/000481093
136. J Am Geriatr Soc. 2016 Sep;64(9):1830-8. doi: 10.1111/jgs.14304. Epub 2016 Aug
22.
Cognitive Behavioral Therapy for Insomnia in Older Veterans Using Nonclinician

Sleep Coaches: Randomized Controlled Trial.
Alessi C(1)(2), Martin JL(3)(4), Fiorentino L(5), Fung CH(3)(4), Dzierzewski

JM(3)(4), Rodriguez Tapia JC(4)(6), Song Y(3)(4), Josephson K(3), Jouldjian S(3),
Mitchell MN(3).
Author information:
(1)Geriatric Research, Education and Clinical Center, Veterans Affairs Greater
Los Angeles Healthcare System, Los Angeles, California. cathy.alessi@va.gov.
(2)Department of Medicine, David Geffen School of Medicine, University of
California at Los Angeles, Los Angeles, California. cathy.alessi@va.gov.
(3)Geriatric Research, Education and Clinical Center, Veterans Affairs Greater
Los Angeles Healthcare System, Los Angeles, California.
(4)Department of Medicine, David Geffen School of Medicine, University of
California at Los Angeles, Los Angeles, California.
(5)Department of Psychiatry, University of California at San Diego, San Diego,
California.
(6)Department of Medicine, Pontificia Universidad Catolica de Chile, Santiago,
Chile.
Comment in
Evid Based Nurs. 2017 Jul;20(3):92.
OBJECTIVES: To test a new cognitive behavioral therapy for insomnia (CBT-I)

program designed for use by nonclinicians.
DESIGN: Randomized controlled trial.
SETTING: Department of Veterans Affairs healthcare system.
PARTICIPANTS: Community-dwelling veterans aged 60 and older who met diagnostic
criteria for insomnia of 3 months duration or longer (N = 159).
INTERVENTION: Nonclinician "sleep coaches" delivered a five-session manual-based
CBT-I program including stimulus control, sleep restriction, sleep hygiene, and
cognitive therapy (individually or in small groups), with weekly telephone
behavioral sleep medicine supervision. Controls received five sessions of general
sleep education.
MEASUREMENTS: Primary outcomes, including self-reported (7-day sleep diary) sleep
onset latency (SOL-D), wake after sleep onset (WASO-D), total wake time (TWT-D),
and sleep efficiency (SE-D); Pittsburgh Sleep Quality Index (PSQI); and objective
sleep efficiency (7-day wrist actigraphy, SE-A) were measured at baseline, at the
posttreatment assessment, and at 6- and 12-month follow-up. Additional measures
included the Insomnia Severity Index (ISI), depressive symptoms (Patient Health
Questionnaire-9 (PHQ-9)), and quality of life (Medical Outcomes Study 12-item
Short-form Survey version 2 (SF-12v2)).
RESULTS: Intervention subjects had greater improvement than controls between the
baseline and posttreatment assessments, the baseline and 6-month assessments, and
the baseline and 12-month assessments in SOL-D (-23.4, -15.8, and -17.3 minutes,
respectively), TWT-D (-68.4, -37.0, and -30.9 minutes, respectively), SE-D
(10.5%, 6.7%, and 5.4%, respectively), PSQI (-3.4, -2.4, and -2.1 in total score,
respectively), and ISI (-4.5, -3.9, and -2.8 in total score, respectively) (all P
< .05). There were no significant differences in SE-A, PHQ-9, or SF-12v2.
CONCLUSION: Manual-based CBT-I delivered by nonclinician sleep coaches improves
sleep in older adults with chronic insomnia.
© 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics
Society.
DOI: 10.1111/jgs.14304
PMCID: PMC5351772
137. Zhen Ci Yan Jiu. 2018 Sep 25;43(9):573-5. doi: 10.13702/j.1000-0607.170765.
[Comparison of Therapeutic Effects Between Thermosensitive Moxibustion and

Medication in the Treatment of Insomnia of Liver-Qi Stagnation Pattern].
Li LC(1), Xing HJ(2), Liang Y(1), Hu YH(1), An X(1), He XX(1), Jia CS(2).
Author information:
(1)Department of Acupunture and Moxibustion, Shijiazhuang Hospital of Traditional
Chinese Medicine, Shijiazhuang 050021, China.
(2)School of Acupuncture-moxibustion and Massage, Hebei College of Traditional
Chinese Medicine, Shijiazhuang 050020.
OBJECTIVE: To compare the therapeutic effect of thermosensitive moxibustion (TSM)

and medication in the treatment of insomnia patients with the syndrome of
stagnation of liver-qi.
METHODS: A total of 60 insomnia patients with the syndrome of liver-qi stagnation
were randomly divided into TSM group and medication group (n ＝ 30 in each). Mild
moxibustion was applied to bilateral Taichong (LR 3) and Qiuxu (GB 40)
alternatively till the patient experienced an intense warmth (diathermic, heat
transmission, etc.) feeling in the local region. The treatment was conducted once
daily for 15 d. Patients of the medication group were ordered to take Estazolam
tablets (1 mg/d) 1 h before sleeping, once daily for successive 15 days. The
sleep quality (sleeping quality, falling asleep time, sleep duration, sleep
efficiency, sleep disorders, hyponotic and day time dysfunction, 0－21 points) was
evaluated by using Pittsburgh Sleep Quality Index (PSQI). The therapeutic effect
was assessed in accordance with the "Guide Principles for Clinical Trials on New
Drugs of Chinese Materia Medica (1993)" and international united sleep efficiency
value.
RESULTS: Following the treatment, the PSQI of both groups were significantly
decreased relevant to their own pre-treatment (P<0.05), but without significant
difference between the two groups (P>0.05). Of the two 30 cases in the medication
and moxibustion groups, 12 (40.00%) and 20 (66.67%) had marked improvement, 7
(23.33%) and 6 (20.00%) were effective, and 11(36.67%) and 4 (13.33%) were
invalid, with the effective rates being 63.33 % (19/30) and 86.67% (26/30),
respectively. The effective rate of the TSM group was significantly higher than
that of the medicine group (P <0.05).
CONCLUSION: Thermosensitive moxibustion applied to the source points of the Liver
and Gallbladder Meridians can improve the quality of sleep in insomnia patients
with syndrome of liver-qi stagnation.
DOI: 10.13702/j.1000-0607.170765
138. Br J Gen Pract. 2015 Aug;65(637):e508-15. doi: 10.3399/bjgp15X686137.
Simplified sleep restriction for insomnia in general practice: a randomised

controlled trial.
Falloon K(1), Elley CR(1), Fernando A 3rd(2), Lee AC(3), Arroll B(1).
Author information:
(1)Department of General Practice and Primary Health Care;
(2)Department of Epidemiology and Biostatistics, University of Auckland,
Auckland, New Zealand.
(3)Department of Psychological Medicine;
Comment in
Evid Based Med. 2015 Dec;20(6):206.
BACKGROUND: Insomnia is common in primary care. Cognitive behavioural therapy for

insomnia (CBT-I) is effective but requires more time than is available in the
general practice consultation. Sleep restriction is one behavioural component of
CBT-I.
AIM: To assess whether simplified sleep restriction (SSR) can be effective in
improving sleep in primary insomnia.
DESIGN AND SETTING: Randomised controlled trial of patients in urban general
practice settings in Auckland, New Zealand.
METHOD: Adults with persistent primary insomnia and no mental health or
significant comorbidity were eligible. Intervention patients received SSR
instructions and sleep hygiene advice. Control patients received sleep hygiene
advice alone. Primary outcomes included change in sleep quality at 6 months
measured by the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index
(ISI), and sleep efficiency (SE%). The proportion of participants reaching a
predefined 'insomnia remission' treatment response was calculated.
RESULTS: Ninety-seven patients were randomised and 94 (97%) completed the study.
At 6-month follow-up, SSR participants had improved PSQI scores (6.2 versus 8.4,
P<0.001), ISI scores (8.6 versus 11.1, P = 0.001), actigraphy-assessed SE%
(difference 2.2%, P = 0.006), and reduced fatigue (difference -2.3 units, P =
0.04), compared with controls. SSR produced higher rates of treatment response
(67% [28 out of 42] versus 41% [20 out of 49]); number needed to treat = 4 (95%
CI = 2.0 to 19.0). Controlling for age, sex, and severity of insomnia, the
adjusted odds ratio for insomnia remission was 2.7 (95% CI = 1.1 to 6.5). There
were no significant differences in other outcomes or adverse effects.
CONCLUSION: SSR is an effective brief intervention in adults with primary
insomnia and no comorbidities, suitable for use in general practice.
© British Journal of General Practice 2015.
DOI: 10.3399/bjgp15X686137
PMCID: PMC4513738
139. Neuroreport. 2018 Aug 15;29(12):981-986. doi: 10.1097/WNR.0000000000001065.
Changes in insular cortex metabolites in patients with obstructive sleep apnea

syndrome.
Kang J(1)(2), Tian Z(1)(3), Li M(1).
Author information:
(1)Department of Respiratory, The First Affiliated Hospital of Jilin University,
Changchun.
(2)Basic Medical College, Jilin Medical University, Jilin.
(3)Department of Respiratory, Jining NO.1 People's Hospital, Jining, People's
Republic of China.
The aim of this study was to investigate the changes in insular cortex
metabolites and the correlation with clinical manifestations in patients with
obstructive sleep apnea syndrome (OSA). Lateral insular metabolite levels were
measured and relevant ratios were calculated in OSA patients and healthy
individuals, including N-acetyl aspartate/creatine (NAA/Cr), choline/creatine
(Cho/Cr), inositol/creatine (Ins/Cr), glutamate compound/creatine (Glx/Cr),
N-acetyl aspartate/choline (NAA/Cho), and lactic acid (Lac). Participants' scores
on the Hamilton Anxiety Scale (HAMA), the Hamilton Depression Scale (HAMD), the
Pittsburgh Sleep Quality Index (PSQI), and the Epworth Sleepiness Scale (ESS)
were also evaluated. Apnea-Hypopnea Index, the lowest arterial oxygen saturation,
and the mean arterial oxygen saturation (MSaO2) values were monitored by
polysomnography. NAA/Cr, Glx/Cr, and NAA/Cho values in the insular cortex were
significantly decreased, whereas HAMA, HAMD, PSQI, and ESS scores were
significantly higher in OSA patients compared with the control participants. HAMA
and HAMD scores showed a significant negative correlation with the NAA/Cho value
in the insular cortex and a positive correlation with PSQI and ESS scores. PSQI
scores were correlated positively with the Cho/Cr and Ins/Cr ratios in the left
insular cortex, but correlated negatively with the NAA/Cho ratio. The symptoms of
anxiety and depression in OSA patients may be associated with insular neuron
damage or dysfunction; proton magnetic resonance spectroscopy can provide an
objective imaging basis for the early diagnosis and treatment of OSA in clinical
practice.
DOI: 10.1097/WNR.0000000000001065
140. Zhongguo Zhen Jiu. 2015 Aug;35(8):768-72.
[Acupuncture treatment of insomnia based on the spleen and stomach theory].
Liu Y, Lin C, Wu H, Wang X, Zhu Y.
OBJECTIVE: To observe the impact of acupuncture on the subjective symptom, sleep

quality and sleep efficiency in the patients of insomnia differentiated as spleen
deficiency or non-spleen deficiency in terms of the spleen and stomach theory.
METHODS: Sixty patients with insomnia were divided into a spleen deficiency group
and a non-spleen deficiency group, 30 cases in each one. In the two groups,
acupuncture was applied at Sishencong (EX-HN1), Shenmen (HT 7), Sanyinjiao (SP
6), Zusanli (ST 36) and Tianshu (ST 25). The treatment was given once every other
day, five times as one course, and two courses were required. The Athens Insomnia
Scale (AIS) was used to observe the changes in the patients' subjective symptoms.
The Pittsburgh sleep quality index (PSQI) was adopted to observe the changes of
patients' sleep quality. The sleep efficiency was applied to observe the changes
in sleep time. The clinical efficacy was determined.
RESULTS: The total effective rate was both 80. 0% (24/30) after 5 and 10
treatments in the spleen deficiency group and was 76. 7% (23/30) and 80. 0%
(24/30) respectively in the non-spleen deficiency group. The differences were not
significant between the two groups (both P >0. 05). The AIS total scores and PSQI
total scores were reduced apparently after 5 and 10 treatments as compared with
those before treatment (all P<0. 01). The difference at each time point was not
significant between the two groups (all P>0. 05). The sleep efficiency after 5
and 10 treatments was all improved as compared with that before the treatment in
the two groups (all P<0. 01).
CONCLUSION: Acupuncture based on the spleen and stomach theory achieves possibly
the same clinical efficacy in the patients of insomnia differentiated as those
with spleen deficiency and non-spleen deficiency. It relieves the subjective
symptoms and improves the sleep quality and sleep efficiency in the patients.
141. Sleep. 2016 Jan 1;39(1):237-47. doi: 10.5665/sleep.5356.
A Collaborative Paradigm for Improving Management of Sleep Disorders in Primary

Care: A Randomized Clinical Trial.
Edinger JD(1)(2), Grubber J(3), Ulmer C(3)(2), Zervakis J(3), Olsen M(3)(2).
Author information:
(1)National Jewish Health, Denver, CO.
(2)Duke University Medical Centers, Durham, NC.
(3)VA, Durham, NC.
Comment in
Am J Respir Crit Care Med. 2017 May 15;195(10 ):1394-1396.
OBJECTIVES: To test a collaborative care model for interfacing sleep specialists

with primary care providers to enhance patients' sleep disorders management.
METHODS: This study used a randomized, parallel group, clinical intervention
trial design. A total of 137 adult (29 women) VA outpatients with sleep
complaints were enrolled and randomly assigned to (1) an intervention (INT)
consisting of a one-time consultation with a sleep specialist who provided
diagnostic feedback and treatment recommendations to the patient and the
patient's primary care provider; or (2) a control condition consisting of their
usual primary care (UPC). Provider-focused outcomes included rates of adherence
to recommended diagnostic procedures and sleep-focused interventions.
Patient-focused outcomes included measures taken from sleep diaries and
actigraphy; Pittsburgh Sleep Quality Index (PSQI) scores; and self-report
measures of sleepiness, fatigue, mood, quality of life, and satisfaction with
health care.
RESULTS: The proportions of provider-initiated sleep-focused interventions were
significantly higher in the INT group than in the UPC group for polysomnography
referrals (49% versus 6%; P < 0.001) and mental health clinic referrals (19%
versus 6%; P = 0.02). At the 10-mo follow up, INT recipients showed greater
estimated mean reductions in diary total wake time (-17.0 min; 95% confidence
interval [CI]: -30.9, -3.1; P = 0.02) and greater increases in sleep efficiency
(+3.7%; 95% CI: 0.8, 6.5; P = 0.01) than did UPC participants. A greater
proportion of the INT group showed ≥ 1 standard deviation decline on the PSQI
from baseline to the 10-mo follow-up (41% versus 21%; P = 0.02). Moreover, 69% of
the INT group had normal (≤ 10) Epworth Sleepiness Scale scores at the 10-mo
follow-up, whereas only 50% of the UPC group fell below this clinical cutoff (P =
0.03).
CONCLUSIONS: A one-time sleep consultation significantly increased healthcare
providers' attention to sleep problems and resulted in benefits to patients'
sleep/wake symptoms.
CLINICAL TRIALS REGISTRATION: This study is registered with clinicaltrials.gov
with identifier # NCT00390572.
© 2016 Associated Professional Sleep Societies, LLC.
DOI: 10.5665/sleep.5356
PMCID: PMC4678353
142. J Appl Gerontol. 2018 Nov;37(11):1327-1343. doi: 10.1177/0733464816663553. Epub

2016 Aug 10.
A Secondary Analysis of Sleep Quality Changes in Older Adults From a Randomized

Trial of an MBSR Program.
Gallegos AM(1), Moynihan J(1), Pigeon WR(1)(2).
Author information:
(1)1 University of Rochester Medical Center, NY, USA.
(2)2 Canandaigua VA Medical Center, NY, USA.
This secondary analysis examined changes in sleep quality associated with

participation in a Mindfulness-Based Stress Reduction (MBSR) program among
healthy older adults. Data were collected at baseline, 8-weeks post-treatment,
and a 6-month follow-up from adults aged ≥ 65 ( N = 200), randomly assigned to
MBSR or a waitlist control. Group differences were examined using mixed analysis
of covariance with repeated measures on the total Pittsburgh Sleep Quality Index
(PSQI) score. A small-sized, significant effect was found on overall sleep among
MBSR participants with baseline PSQI scores > 5, indicative of a sleep
disturbance, F(2, 80) = 4.32, p = .02, ηp2 = .05. A medium-sized, significant
effect was found for MBSR participants with baseline PSQI scores ≥ 10, F(2, 28) =
3.13, p = .04, ηp2 = .10. These findings indicate that improved sleep quality for
older adults who have higher levels of sleep disturbance may be associated with
participation in MBSR.
DOI: 10.1177/0733464816663553
PMCID: PMC5874181
143. Explore (NY). 2018 Sep;14(5):373-378. doi: 10.1016/j.explore.2018.01.002. Epub

2018 Jun 28.
Add-on Effect Of Hot Sand Fomentation To Yoga On Pain, Disability, And Quality Of
Life In Chronic Neck Pain Patients.
Nandini B(1), Mooventhan A(2), Manjunath NK(3).
Author information:
(1)Division of Yoga and Life Sciences, The School of Yoga and Naturopathic
Medicine, S-VYASA University, Bengaluru, Karnataka, India.
(2)Senior Medical Officer (Yoga), Center for Integrative Medicine and Research
(CIMR), All India Institute of Medical Sciences (AIIMS), New Delhi, India;
Department of Research and Development, Division of Yoga and Life Sciences,
S-VYASA University, Bengaluru, Karnataka, India. Electronic address:
dr.mooventhan@gmail.com.
(3)Division of Yoga and Life Sciences, & Head, Department of Research and
Development, S-VYASA University, Bengaluru, Karnataka, India.
BACKGROUND: Neck pain is one of the commonest complaints and an important public
health problem across the globe. Yoga has reported to be useful for neck pain and
hot sand has reported to be useful for chronic rheumatism. The present study was
conducted to evaluate the add-on effect of hot sand fomentation (HSF) to yoga on
pain, disability, quality of sleep (QOS) and quality of life (QOL) of the
patients with non-specific neck pain.
MATERIALS AND METHODS: A total of 60 subjects with non-specific or common neck
pain were recruited and randomly divided into either study group or control
group. Both the groups have received yoga and sesame seed oil (Sesamum Indicum
L.) application. In addition to yoga and sesame seed oil, study group received
HSF for 15 min per day for 5-days. Assessments were taken prior to and after the
intervention.
RESULTS: Results of the study showed a significant reduction in the scores of
visual analogue scale for pain, neck disability index (NDI), The Pittsburgh Sleep
Quality Index (PSQI), and a significant increase in physical function, physical
health, emotional problem, pain, and general health both in study and control
groups. However, reductions in pain and NDI along with improvement in social
functions were better in the study group as compared with control group.
CONCLUSION: Results of this study suggest that addition of HSF to yoga provides a
better reduction in pain and disability along with improvement in the social
functioning of the patients with non-specific neck pain than yoga alone.
DOI: 10.1016/j.explore.2018.01.002
144. Med Educ Online. 2017;22(1):1379345. doi: 10.1080/10872981.2017.1379345.
Night duty and decreased brain activity of medical residents: a wearable optical
topography study.
Nishida M(1)(2), Kikuchi S(1)(3), Miwakeichi F(4)(5), Suda S(1).
Author information:
(1)a Department of Psychiatry , Jichi Medical University , Shimotsuke , Japan.
(2)b Faculty of Sports Science , Waseda University , Tokorozawa , Japan.
(3)c Department of Rehabilitation Sciences , Gunma University Graduate School of
Health Sciences , Maebashi , Japan.
(4)d Department of Statistical Modeling , The Institute of Statistical
Mathematics , Tachikawa , Japan.
(5)e Department of Statistical Science, School of Multidisciplinary Sciences ,
Graduate University for Advanced Studies , Tachikawa , Japan.
BACKGROUND: Overwork, fatigue, and sleep deprivation due to night duty are likely
to be detrimental to the performance of medical residents and can consequently
affect patient safety.
OBJECTIVE: The aim of this study was to determine the possibility of
deterioration of cerebral function of sleep-deprived, fatigued residents using
neuroimaging techniques.
DESIGN: Six medical residents were instructed to draw blood from artificial
vessels installed on the arm of a normal cooperator. Blood was drawn at a similar
time of the day, before and after night duty. To assess sleep conditions during
night duty, the participants wore actigraphy units throughout the period of night
duty. Changes in cerebral hemodynamics, during the course of drawing blood, were
measured using a wearable optical topography system.
RESULTS: The visual analogue scale scores after night duty correlated negatively
with sleep efficiency during the night duty (ρ = -0.812, p = 0.050). The right
prefrontal cortex activity was significantly decreased in the second trial after
night duty compared with the first (p = 0.028). The extent of [oxy-Hb] decrease,
indicating decreased activity, in the right dorsolateral prefrontal cortex
correlated negatively with the Epworth sleepiness score after night duty
(ρ = -0.841, p = 0.036).
CONCLUSIONS: Sleep deprivation and fatigue after night duty, caused a decrease in
the activity of the right dorsolateral prefrontal cortex of the residents, even
with a relatively easy routine. This result implies that the brain activity of
medical residents exposed to stress on night duty, although not substantially
sleep-deprived, was impaired after the night duty, even though they apparently
performed a simple medical technique appropriately. Reconsideration of the shift
assignments of medical residents is strongly advised.
ABBREVIATIONS: DLPFC: Dorsolateral prefrontal cortex; ESS: Epworth sleepiness
scale; PSQI: Pittsburgh sleep quality index; ROI: Regions of interest; VAS:
Visual analogue scale; WOT: Wearable optical topography.
DOI: 10.1080/10872981.2017.1379345
PMCID: PMC5653933
145. Altern Ther Health Med. 2017 Jul;23(4). pii: at5471. Epub 2017 Feb 27.
Comparison Between Acupuncture and Biofeedback as Adjunctive Treatments for

Primary Insomnia Disorder.
Huang HT, Lin SL, Lin CH, Tzeng DS.
Context • Insomnia affects from 5% to 35% of the general population worldwide.

Primary insomnia disorder is the most frequently diagnosed, sleep-related
disorder. Pharmacological treatments remain the most widely used treatments for
insomnia. Nonpharmacological treatments for primary insomnia disorder have been
found to be effective. Objective • This study intended to determine the
appropriateness of acupuncture and biofeedback as adjuncts to medication for
primary insomnia disorder. Design • The research team designed a randomized,
controlled study. Setting • The study took place in a psychosomatic clinic at a
regional general hospital in southern Taiwan. Participants • Participants were
patients at the clinic with primary insomnia disorder who had never received
prior hypnotic medication or alternative treatments. Intervention • All
participants received 10 mg of zolpidem. The participants were divided into 3
groups: (1) acupuncture adjunctive to zolpidem (AAZ) group- 18 patients received
1 acupuncture session weekly; (2) biofeedback adjunctive to zolpidem (BAZ) group-
17 patients received 1 biofeedback session weekly; and (3) control (OZ) group-14
patients received only zolpidem. Patients visited the clinic 1 ×/wk for 4 wk, at
baseline and on days 7, 14, and 21 of the intervention. Outcome Measures • The
Pittsburgh Sleep Quality Index (PSQI) was used to measure outcomes. Treatment
success was defined as a final PSQI score of ≤5. The generalized estimating
equation (GEE) was used for statistical analysis. Results • Using analysis of
variance, the reduction in the PSQI scores were (1) 3.72 for the AAZ group, (2)
2.00 for the BAZ group, and (3) 2.29 for the OZ group (P = .28). The GEE analysis
indicated no differences in the therapeutic effects among the 3 groups: P = .37
for the AAZ group vs the OZ group and P = .07 for the BAZ group vs the OZ group,
when the PSQI of the OZ group was set to 0. The AAZ group had a significantly
higher score than the OZ group for the sleep duration domain (B = 3.01, P <
.001), whereas the BAZ group had a significantly higher score than the OZ group
on the sleep disturbance domain (B = 6.78, P < .001). Higher scores indicate more
difficulty in a domain. Conclusions • The change in the PSQI score and the
success rate were better in the acupuncture group. The heterogeneity in primary
insomnia disorder might mean that different therapeutic compositions are needed.
146. Nihon Koshu Eisei Zasshi. 2018;65(8):386-398. doi: 10.11236/jph.65.8_386.
[Effects of Brief Cognitive Behavioral Therapy for insomnia on sleep and usage of
hypnotics among community-dwelling older adults: Randomized controlled trial].
[Article in Japanese]
Tanaka M(1), Ikeuchi M(2), Matsuki H(2), Yaguchi K(2), Kutsuzawa T(2), Tanaka
K(3), Kaneita Y(4).
Author information:
(1)Kitasato University School of Nursing.
(2)Tokai University School of Health Sciences.
(3)Kitasato University Graduate School of Medical sciences.
(4)Nihon University School of Medicine.
Objectives　Chronic insomnia is common in late adulthood. A non-pharmacological

approach should take priority in the treatment of insomnia for the elderly. Many
studies have shown the efficacy of Cognitive Behavioral Therapy for Insomnia
(CBT-I) for elderly diagnosed with insomnia. However the effect of CBT-I on mild
insomnia among older adults in community settings has not been ascertained. We
conducted a randomized controlled trial to evaluate the effectiveness of a brief
CBT-I delivered by nurses, which is feasible in community settings, to improve
sleep quality and decrease the dose of hypnotics use for older
adults.Methods　Participants aged 60 years and over were enrolled in this study.
The participants in the intervention group were administrated the brief CBT-I
consisting of a group session (60 min) and an individual session (30 min). The
primary outcomes were the score differences in the Pittsburgh Sleep Quality Index
(PSQI) and Insomnia Severity Index (ISI). The secondary outcomes were the change
in the proportion of people diagnosed with insomnia and the dose of hypnotics
used. The follow-up period was 3 months.Results　The score on PSQI in the
intervention group (n=41) significantly decreased compared to the control group
(n=38). The effect size (Cohen's d) was 0.56 (95% Confidence interval [CI], 0.07
to 1.05). The score on ISI also decreased significantly and Cohen's d was 0.77
(95%CI, 0.27 to 1.26). According to subgroup analysis, Number Needed to Treat
(NNT) for improvement of insomnia was 2.8 (95%CI, 1.5-17.2) and NNT for
decreasing of dose of hypnotics use was 2.8 (95%CI, 1.5-45.1).Conclusion　The
present results have demonstrated that the brief CBT-I significantly improved
subjective evaluation of sleep quality and insomnia symptoms among the elderly.
In addition, the brief CBT-I decreased the usage of hypnotics. Further studies
are needed in terms of the procedure and the effects of brief CBT-I for older
adults living in a community.
DOI: 10.11236/jph.65.8_386
147. Am J Clin Nutr. 2016 Mar;103(3):766-74. doi: 10.3945/ajcn.115.124669. Epub 2016

Feb 10.
Higher-protein diets improve indexes of sleep in energy-restricted overweight and

obese adults: results from 2 randomized controlled trials.
Zhou J(1), Kim JE(1), Armstrong CL(1), Chen N(2), Campbell WW(3).
Author information:
(1)Departments of Nutrition Science and.
(2)Statistics, Purdue University, West Lafayette, IN.
(3)Departments of Nutrition Science and campbellw@purdue.edu.
BACKGROUND: Limited and inconsistent research findings exist about the effect of
dietary protein intake on indexes of sleep.
OBJECTIVE: We assessed the effect of protein intake during dietary energy
restriction on indexes of sleep in overweight and obese adults in 2 randomized,
controlled feeding studies.
DESIGN: For study 1, 14 participants [3 men and 11 women; mean ± SE age: 56 ± 3
y; body mass index (BMI; in kg/m(2)): 30.9 ± 0.6] consumed energy-restricted
diets (a 750-kcal/d deficit) with either beef and pork (BP; n = 5) or soy and
legume (SL; n = 9) as the main protein sources for 3 consecutive 4-wk periods
with 10% (control), 20%, or 30% of total energy from protein (random order). At
baseline and the end of each period, the global sleep score (GSS) was assessed
with the use of the Pittsburgh Sleep Quality Index (PSQI) questionnaire. For
study 2, 44 participants (12 men and 32 women; age: 52 ± 1 y; BMI: 31.4 ± 0.5)
consumed a 3-wk baseline energy-balance diet with 0.8 g protein · kg baseline
body mass(-1) · d(-1). Then, study 2 subjects consumed either a normal-protein
[NP (control); n = 23] or a high-protein (HP; n = 21) (0.8 compared with 1.5 g ·
kg(-1) · d(-1), respectively) energy-restricted diet (a 750-kcal/d deficit) for
16 wk. The PSQI was administered during baseline week 3 and intervention weeks 4,
8, 12, and 16. GSSs ranged from 0 to 21 arbitrary units (au), with a higher value
representing a worse GSS during the preceding month.
RESULTS: In study 1, we showed that a higher protein quantity improved GSSs
independent of the protein source. The GSS was higher (P < 0.05) when 10% (6.0 ±
0.4 au) compared with 20% (5.0 ± 0.4 au) protein was consumed, with 30% protein
(5.4 ± 0.6 au) intermediate. In study 2, at baseline, the GSS was not different
between NP (5.2 ± 0.5 au) and HP (5.4 ± 0.5 au) groups. Over time, the GSS was
unchanged for the NP group and improved for the HP group (P-group-by-time
interaction < 0.05). After intervention (week 16), GSSs for NP and HP groups were
5.9 ± 0.5 and 4.0 ± 0.6 au, respectively (P < 0.01).
CONCLUSION: The consumption of a greater proportion of energy from protein while
dieting may improve sleep in overweight and obese adults. This trial was
registered at clinicaltrials.gov as NCT01005563 (study 1) and NCT01692860 (study
2).
© 2016 American Society for Nutrition.
DOI: 10.3945/ajcn.115.124669
PMCID: PMC4763499 [Available on 2017-03-01]
148. BMJ Support Palliat Care. 2016 Mar;6(1):89-93. doi:

10.1136/bmjspcare-2014-000691. Epub 2014 Sep 12.
Restless legs syndrome in patients with type 2 diabetes: effectiveness of

pramipexole therapy.
Harashima S(1), Nishimura A(2), Osugi T(1), Wang Y(3), Liu Y(3), Takayama H(4),
Inagaki N(3).
Author information:
(1)Department of Diabetes, Endocrinology and Nutrition, Graduate School of
Medicine, Kyoto University, Kyoto, Japan Department of Internal Medicine,
Takashima Citizen Hospital, Takashima, Japan.
(2)Department of Human Health Science, Graduate School of Medicine, Kyoto
University, Kyoto, Japan.
(3)Department of Diabetes, Endocrinology and Nutrition, Graduate School of
Medicine, Kyoto University, Kyoto, Japan.
(4)Department of Internal Medicine, Takashima Citizen Hospital, Takashima, Japan.
OBJECTIVE: We investigated the prevalence of restless legs syndrome (RLS) in

Japanese patients with type 2 diabetes and assessed the efficacy of pramipexole
therapy.
DESIGN: One hundred patients with type 2 diabetes without secondary causes of RLS
were sequentially screened for the 12-week, prospective, single arm study. RLS
was screened by essential diagnostic criteria developed by the International
Restless Legs Study Group. Diabetic neuropathy was diagnosed by nerve conductance
study. Severity of RLS and sleep quality were assessed by the International
Restless Legs Rating Scale (IRLS) and the Japanese version of the Pittsburgh
Sleep Quality Index (PSQI-J), respectively. Pramipexole was administered for
12 weeks. The primary end point was change in the IRLS score in 12 weeks and
secondary end points were change in PSQI-J and glycated haemoglobin (HbA1c) in
12 weeks.
RESULTS: RLS was diagnosed in 8 of 100 participants (8%). Diabetic neuropathy was
most likely associated with RLS (OR 3.81, 95% CI 0.85 to 17.05, p=0.111). The
IRLS score was improved from 19.0±5.6 to 5.4±4.8 by pramipexole in 12 weeks
(p<0.001). The change in the score was -13.6 (95% CI -15.5 to -11.7; p<0.05).
PSQI-J was improved from 6.0±4.4 to 1.5±1.3 in 12 weeks (p<0.05). Change in
PSQI-J was -4.5 (95% CI -6.8 to -2.1; p<0.05). HbA1c was slightly decreased from
7.19±0.56% (55±6 mmol/mol) to 6.90±0.48% (52±5 mmol/mol) in 12 weeks (p<0.05).
Change in HbA1c was -0.29% (-3 mmol/mol) (95% CI -0.37% to -0.20% (-4 to
-2 mmol/mol;) p<0.05).
CONCLUSIONS: We find that type 2 diabetes is a possible risk factor for RLS in
the Japanese population, and that pramipexole treatment can improve the symptoms
of RLS as well as the quality of sleep and glycaemic control in these patients.
TRIAL REGISTRATION NUMBER: University hospital Medical Information Network in
Japan (UMIN000008347).
Published by the BMJ Publishing Group Limited. For permission to use (where not
already granted under a licence) please go to
http://www.bmj.com/company/products-services/rights-and-licensing/
DOI: 10.1136/bmjspcare-2014-000691
149. HIV Med. 2017 Oct;18(9):690-695. doi: 10.1111/hiv.12503. Epub 2017 Mar 1.
Does efavirenz replacement improve neurological function in treated HIV

infection?
Payne B(1)(2), Chadwick TJ(3), Blamire A(4), Anderson KN(5), Parikh J(4), Qian
J(6), Hynes AM(6), Wilkinson J(6), Price DA(1); Efficacy of Switch to
Lopinavir/Ritonavir in Improving Cognitive Function in Efavirenz-treated Patients
(SLICE) study team.
Author information:
(1)Department of Infection and Tropical Medicine, The Newcastle Upon Tyne
Hospitals NHS Foundation Trust, Newcastle, UK.
(2)Wellcome Trust Centre for Mitochondrial Research, Institute of Genetic
Medicine, Newcastle University, Newcastle, UK.
(3)Institute of Health and Society, Newcastle University, Newcastle, UK.
(4)Centre for In Vivo Imaging, Newcastle University, Newcastle, UK.
(5)Regional Sleep Service, The Newcastle Upon Tyne Hospitals NHS Foundation
Trust, Newcastle, UK.
(6)Newcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.
OBJECTIVES: The contribution of specific antiretroviral drugs to cognitive

function in HIV-infected people remains poorly understood. Efavirenz (EFV) may
plausibly cause cognitive impairment. The objective of this study was therefore
to determine whether chronic EFV therapy is a modifier of neurocognitive and
neurometabolic function in the setting of suppressive highly active
antiretroviral therapy.
METHODS: We performed an open-label phase IV controlled trial. Adult subjects who
were stable on suppressive EFV therapy for at least 6 months were switched to
ritonavir-boosted lopinavir (LPV/r) with no change in the nucleoside reverse
transcriptase inhibitor (NRTI) backbone. The following parameters were assessed
before and 10 weeks after therapy switch: cognitive function (by CogState®
computerized battery); brain metabolites (by proton magnetic resonance
spectroscopy); brain activity [by attentional processing task-based functional
magnetic resonance imaging]; and sleep quantity and quality [by sleep diary,
Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale].
RESULTS: Sixteen subjects completed the study. Despite most subjects (81%)
self-reporting memory problems at baseline, cognitive function, brain
metabolites, and brain activity showed no change at 10 weeks after switch. Sleep
quality improved on switch off EFV [mean PSQI (standard deviation): EFV, 8.5
(6.5); LPV/r, 5.8 (5.5); mean difference -0.4; 95% confidence interval -6.0 to
-0.7].
CONCLUSIONS: This is the first study to assess the effects of chronic EFV therapy
on neurological function in a controlled setting. We conclude that EFV withdrawal
is unlikely to result in significant modification of neurocognitive function in
otherwise stable HIV-infected people.
© 2017 The Authors HIV Medicine published by John Wiley & Sons Ltd on behalf of
British HIV Association.
DOI: 10.1111/hiv.12503
PMCID: PMC5600135
150. Arch Gynecol Obstet. 2016 May;293(5):1007-13. doi: 10.1007/s00404-015-3900-1.

Epub 2015 Oct 5.
Comparison of citalopram and venlafaxine's role in treating sleep disturbances in

menopausal women, a randomized, double-blind, placebo-controlled trial.
Davari-Tanha F(1), Soleymani-Farsani M(2), Asadi M(3), Shariat M(4), Shirazi

M(2), Hadizadeh H(2).
Author information:
(1)Department of OBS & GYN, Women Hospital-Vali-e-Asr Health Research Center,
Tehran University of Medical Sciences, Tehran, Iran. fatedavtanha@gmail.com.
(2)Department of OBS & GYN, Women Hospital-Vali-e-Asr Health Research Center,
Tehran University of Medical Sciences, Tehran, Iran.
(3)Endocrinology and Metabolism Research Center, Endocrinology and Metabolism
Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
(4)Maternal Fetal Neonatal Research Center, Tehran University of Medical
Sciences, Tehran, Iran.
INTRODUCTION: Sleep disturbance is a common complaint in postmenopausal women.

Few studies compared symptom improvement taking antidepressants versus placebo.
This study aims to evaluate the efficacy of venlafaxine and Citalopram compared
to placebo in treatment of sleep disturbance in healthy postmenopausal women.
METHOD: This randomized, double-blind, placebo-controlled clinical trial was
conducted in three groups of 20 postmenopausal women. The patients took
venlafaxine 75 mg/daily (group I) or citalopram 20 mg/d (group II) or placebo
(group III). Each patient filled Pittsburgh sleep quality index (PSQI) and
Pittsburgh and Beck depression questionnaires. The frequency of hot flashes in a
day and its severity were measured through diaries. Somatic symptoms and adverse
side effects were evaluated. Follow-up visit was conducted after 3 months. The
prior and the later results were compared.
RESULTS: The PSQI scores in three placebo, venlafaxine, and citalopram groups
before treatment were 14.25 ± 3.85, 11.55 ± 3.96, and 13.50 ± 3.56, respectively
(p = 0.076). These values after treatment reached 9.95 ± 5.07, 8 ± 3.06, and 6.95
± 1.84, respectively. PSQI score in citalopram and venlafaxine group was not
significantly different (p = 0.19) but the score in both groups was significantly
lower compared with placebo group after treatment (p = 0.01). The frequency of
hot flashes in a day was reduced significantly by both citalopram and venlafaxine
(p < 0.05), although it was more reduced by citalopram than venlafaxine (p =
0.03). Severity of hot flashes in both venlafaxine and citalopram was
significantly lower in comparison with placebo group (p = 0.02), and there was no
significant difference between two drugs, though (p = 0.84). Beck score decreased
more in venlafaxine group in comparison with other groups but it did not reach
significant (p = 0.06).
CONCLUSION: Citalopram and venlafaxine are equally more effective than placebo in
reducing sleep disturbance and severity of hot flashes, while citalopram is more
effective in reducing frequency of hot flashes than venlafaxine. Meanwhile,
venlafaxine is more effective than citalopram in treatment of depression in
postmenopausal women.
TRIAL REGISTRATION: Iranian Registry of Clinical Trials 201210152576N6.
DOI: 10.1007/s00404-015-3900-1
151. J Clin Sleep Med. 2017 Feb 15;13(2):267-274. doi: 10.5664/jcsm.6460.
Computerized Cognitive Behavioral Therapy for Insomnia in a Community Health

Setting.
Feuerstein S(1)(2), Hodges SE(1), Keenaghan B(2), Bessette A(1), Forselius E(1),
Morgan PT(1).
Author information:
(1)Yale University Department of Psychiatry, New Haven, CT.
(2)Magellan Healthcare, Avon, CT.
Comment in
J Clin Sleep Med. 2017 Feb 15;13(2):161-162.
STUDY OBJECTIVES: Insomnia, though quite common in the general population, is

especially prevalent among individuals with co-occurring mental illnesses,
patients whose condition can be further exacerbated by insomnia and vice versa.
For individuals taking one or more psychotropic medications, cognitive behavioral
therapy for insomnia (CBT-I), the gold standard in insomnia treatment, is a
particularly favorable option (vis-à-vis pharmacotherapy). However, CBT-I can be
inaccessible for persons with low socioeconomic status, a group that includes
many with psychiatric diagnoses. Computer-based delivery of CBT-I (cb-CBT-I) has
the potential to be a cost-effective tool that could greatly improve
accessibility for this at-risk demographic.
METHODS: Thirty-four participants with insomnia who were currently engaged in
mental health care treatment were randomized to an active control group (sleep
diary group; n = 16) or cb-CBT-I (n = 18) during weekly outpatient sessions over
the course of 6 w. All participants completed sleep and activity logs at each
appointment, whereas those in the cb-CBT-I group also completed one session of
the cb-CBT-I program each week.
RESULTS: cb-CBT-I treatment was associated with lower scores (improved sleep) on
the Pittsburgh Sleep Quality Index (PSQI). Post hoc tests demonstrated a between
groups difference at week 6 (p = 0.02), with a statistically significant decrease
in PSQI scores in the cb-CBT-I group (p = 0.0006) but not in the sleep diary
group (p = 0.35).
CONCLUSIONS: cb-CBT-I improves sleep in individuals with insomnia and
co-occurring mental illness. The significant improvements on the PSQI suggest
that implementing a cb-CBT-I treatment in a community mental health center would
be a simple and effective treatment for improving sleep over a short period of
time.
COMMENTARY: A commentary on this article appears in this issue on page 161.
© 2017 American Academy of Sleep Medicine
DOI: 10.5664/jcsm.6460
PMCID: PMC5263082
152. Psychiatry Res. 2018 Dec;270:394-403. doi: 10.1016/j.psychres.2018.09.060. Epub

2018 Oct 2.
An evaluation of a low intensity mHealth enhanced mindfulness intervention for

Chinese university students: A randomized controlled trial.
Hall BJ(1), Xiong P(2), Guo X(2), Sou EKL(3), Chou UI(2), Shen Z(2).
Author information:
(1)Global and Community Mental Health Research Group, Department of Psychology,
The University of Macau, E21-3040, Avenida da Universidade, Taipa, Macau;
Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of
Public Health, Baltimore, MD, USA. Electronic address: brianhall@umac.mo.
(2)Global and Community Mental Health Research Group, Department of Psychology,
The University of Macau, E21-3040, Avenida da Universidade, Taipa, Macau.
(3)Student Counselling Section, Student Affairs Office, The University of Macau,
Macau.
Mental disorders and sleep dysfunction are common among Chinese university
students. This study aimed to evaluate a low cost scalable mindfulness
intervention program to improve psychological health and sleep quality among
Chinese university students. A randomized controlled trial with 101 university
students (mean age 22.30 ± 2.63, 69.31% female) was conducted. Participants were
randomized into 4 groups: Group 1: control group (n = 25), Group 2: mindfulness
only group (n = 27), Group 3: mindfulness + plain-text reminder group (n = 24),
and Group 4: mindfulness + enhanced text reminder with animal meme group
(n = 25).The mindfulness intervention consisted of two in-person guided sessions
along with weekly self-guided practice for 7 weeks. The Depression, Anxiety and
Stress Scale (DASS-21) and The Pittsburgh Sleep Quality Index (PSQI) were used to
measure depression, anxiety, stress, and sleep dysfunction. After the
intervention at week 4, compared to controls, completers in group 2, 3 and 4
(n = 42) showed significantly reduced depression (Cohen's d = 0.83), anxiety
(Cohen's d = 0.84), and stress (Cohen's d = 0.75), and improved subjective sleep
quality (Cohen's d = 2.00), sleep latency (Cohen's d = 0.55), and habitual sleep
efficiency (Cohen's d = 0.86). The effect was maintained at week 7. Low-intensity
mindfulness interventions might be a useful intervention program in university
settings.
DOI: 10.1016/j.psychres.2018.09.060
153. Medicine (Baltimore). 2017 Nov;96(47):e8906. doi: 10.1097/MD.0000000000008906.
Wendan decoction for primary insomnia: Protocol for a systematic review and
meta-analysis.
Yan X(1), Wang Y(2), Li X(2), Li Z(2), Zhang Y(2), Cai X(2), Wang D(1)(3).
Author information:
(1)2nd Affiliated Hospital of Guangzhou University of Chinese Medicine,
Guangzhou.
(2)Guangzhou University of Chinese Medicine, Guangzhou, China.
(3)Guangdong Provincial Key Laboratory of Research on Emergency in TCM.
BACKGROUND: Insomnia is a widespread complaint in the general population. Wendan

decoction has been widely applied in the treatment of primary insomnia. However,
to our knowledge, there has been no systematic review or meta-analysis of
randomized controlled trails regarding the effectiveness of this treatment. Here,
we provide a protocol to evaluate the efficacy and safety of Wendan decoction for
primary insomnia.
METHODS AND ANALYSIS: Relevant randomized controlled trials in 5 English
databases [EMBASE, the Cochrane Central Register of Controlled Trials (Cochrane
Library), PubMed, the Allied and Complementary Medicine Databases (AMED), and the
Cumulative Index to Nursing and Allied Health Literature (CINAHL)], 4 Chinese
databases [Chinese Biomedical Literature Database (CBM), Chinese Medical Current
Content (CMCC), China National Knowledge Infrastructure (CNKI), and Wanfang
Database] will be comprehensively searched by 2 researchers in October 2017. The
therapeutic effects according to the Pittsburgh Sleep Quality Index (PSQI) will
be accepted as the primary outcomes. We will use RevMan V.5.3 software as well to
compute the data synthesis carefully when a metaanalysis is allowed.
RESULTS: This study will provide a high-quality synthesis of current evidence of
Wendan decoction for primary insomnia from several aspects including PSQI, the
total scores of the Insomnia Severity Index (ISI), syndrome according to
standards for assessing Traditional Chinese medicine and adverse events.
CONCLUSION: The conclusion of our systematic review will provide evidence to
judge whether Wendan decoction is an effective intervention for patient with
primary insomnia.
ETHICS AND DISSEMINATION: The outcomes of this systematic review will offer
implications of the use of Wendan decoction treatment for primary insomnia
patients. This knowledge informing recommendations will be provided by
researchers who are interested in the treatment of primary insomnia. The results
of this study will be disseminated through presentation at a conference and
publication of the data in a peer-reviewed journal.
PROSPERO REGISTRATION NUMBER: PROSPERO CRD 42017065664.
Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights
reserved.
DOI: 10.1097/MD.0000000000008906
PMCID: PMC5709024
154. Eur Arch Otorhinolaryngol. 2016 Nov;273(11):3891-3895. Epub 2016 Apr 13.
Efficacy of daytime transcutaneous electrical stimulation of the genioglossus

muscle in patients with obstructive sleep apnea syndrome: short report.
Chwieśko-Minarowska S(1), Minarowski Ł(2), Szewczak WA(3), Chyczewska E(2),

Kuryliszyn-Moskal A(3).
Author information:
(1)Department of Rehabilitation, Medical University of Bialystok, M.
Sklodowska-Curie 24A St, 15-276, Bialystok, Poland. sylwia.chwiesko@umb.edu.pl.
(2)Department of Lung Diseases and Tuberculosis, Medical University of Bialystok,
Bialystok, Poland.
(3)Department of Rehabilitation, Medical University of Bialystok, M.
Sklodowska-Curie 24A St, 15-276, Bialystok, Poland.
Obstructive sleep apnea syndrome (OSAS) is characterized by hypotonia of lingual

and suprahyoid muscles. Genioglossus muscle is responsible for protrusion and
depression of the tongue. Its dysfunction results in occlusion of the upper
airways and greater incidence of apnea-hypopnea events during sleep. The aim of
this prospective study was to compare the effects of daytime transcutaneous
electrical stimulation of the genioglossus muscle and standard continuous
positive airway pressure (CPAP) therapy on the quality of sleep, in patients with
OSAS. During a 4-week study period, 19 patients with OSAS were subjected to
daytime transcutaneous electrical stimulation of the genioglossus muscle before
sleep and another 19 subjects underwent standard CPAP therapy. Polysomnography
(apnea-hypopnea index, AHI), Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep
Quality Index (PSQI) were used to diagnose OSAS and to verify the efficacy of
both treatments. Electrical stimulation treatment was reflected by a decrease in
PSQI (p = 0.012) but did not influence ESS and AHI values (p > 0.05). In turn,
CPAP therapy resulted in a significant decrease in ESS and AHI values (p < 0.001)
but exerted no effect on PSQI (p = 0.089). Despite improvement of sleep quality,
electrical stimulation does not seem to reduce AHI values in patients with OSAS.
Daytime electrical stimulation can be considered as an adjunct treatment in OSAS.
Future prospective studies should center on the identification of patients with
OSAS who may benefit most from transcutaneous electrical stimulation.
DOI: 10.1007/s00405-016-4047-9
155. Metab Syndr Relat Disord. 2018 Feb;16(1):13-19. doi: 10.1089/met.2017.0069. Epub
2018 Jan 22.
Effect of Diabetes Sleep Education for T2DM Who Sleep After Midnight: A Pilot
Study from China.
Li M(1), Li D(1), Tang Y(1), Meng L(1), Mao C(1), Sun L(1), Chang B(1), Chen
L(1).
Author information:
(1)Key Laboratory of Hormones and Development (Ministry of Health), Tianjin Key
Laboratory of Metabolic Diseases, Tianjin Metabolic Diseases Hospital and Tianjin
Institute of Endocrinology, Tianjin Medical University , Tianjin, China .
BACKGROUND: Our prior study showed that patients with sleep disorders had poor
blood pressure (BP), glycemic control, and more severe complications. Therefore,
sleep is very important for diabetic control. Our work was to investigate whether
individualized diabetes sleep education significantly improve sleep quality and
glycemic control in type 2 diabetic patients who sleep after midnight and
potential mechanism by a randomized parallel interventional study.
METHODS: T2D patients were randomly recruited to an intervention or control
group. Patients received structured special diabetes sleep education program with
3-month follow-up. Pittsburg Sleep Quality Index (PSQI) was scored for each
participant. Demographic data, HbA1c, biochemical, and some hormones were also
examined. SPSS 13.0 was used for statistical analysis.
RESULTS: One hundred patients were approached, and 45 were enrolled into our
trial. Eventually, 31 patients completed the study. Patients in the intervention
group greatly improved their sleep hygiene. After intervention, PSQI scores were
lowered significantly (-1.48 ± 0.88 vs. -0.51 ± 0.71, P < 0.001), as well as
significant reduction of HbA1c (-1.5 ± 0.55 vs. -1.11 ± 0.47, P < 0.05). Fasting
plasma glucose was also lowered significantly. Homeostasis model assessment of
insulin resistance was reduced significantly (-1.29 ± 0.97 vs. 1.04 ± 0.91,
P < 0.01). Serum concentrations for interleukin (IL)-6, cortisol, and ghrelin
were decreased significantly. Ghrelin (coefficients -0.65, P < 0.001), cortisol
(coefficients -0.38, P < 0.05), and IL-6 (coefficients 0.452, P < 0.05) were
correlated with HbA1c improvement. The change of ghrelin was negatively
associated with the improvement of HbA1c.
CONCLUSION: Diabetes sleep education could improve sleep quality, better blood
glucose and BP, and decrease insulin resistance through healthier sleep hygiene.
Lower serum concentration of ghrelin might be partly involved in the reduction of
HbA1c.
DOI: 10.1089/met.2017.0069

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