American Journal of Otolaryngology–Head and Neck Medicine and Surgery 38 (2017) 603–607

Contents lists available at ScienceDirect

American Journal of Otolaryngology–Head and Neck

Medicine and Surgery
journal homepage: www.elsevier.com/locate/amjoto

Treatment of laryngopharyngeal reflux using a sleep positioning device:

A prospective cohort study☆
William S. Tierney a,⁎, Scott L. Gabbard b, Claudio F. Milstein a, Michael S. Benninger a, Paul C. Bryson a
a
Cleveland Clinic Head and Neck Institute, 9500 Euclid Ave/A71, Cleveland, OH 44195, United States
b
Cleveland Clinic Digestive Disease Institute, 9500 Euclid Ave/A31, Cleveland, OH 44106, United States

a r t i c l e i n f o a b s t r a c t

Article history: Objective: Laryngopharyngeal reflux (LPR) symptoms are often resistant to management and cause significant
Received 6 June 2017 quality of life impairment to patients with this disease. This study assesses the utility of a sleep-positioning device
(SPD) in treating LPR.
Keywords: Design: Single center prospective cohort study.
Laryngopharyngeal reflux Setting: Tertiary medical center
Reflux
Participants: 27 adult patients with diagnosed laryngopharyngeal reflux.
Sleep positioning device
Wedge
Intervention: An SPD consisting of a two-component wedge-shaped base pillow and a lateral positioning body pil-
Pillow low (Medcline, Amenity Health Inc.) was given to patients with a diagnosis of LPR. Subjects slept using the device
Cohort study for at least 6 h per night for 28 consecutive nights.
Medcline Main outcomes: Primary outcomes were Nocturnal Gastroesophageal Reflux Symptom Severity and Impact Ques-
Gerd tionnaire (N-GSSIQ) and the Reflux Symptoms Index (RSI) survey instrument. Each was collected at baseline,
Lpr after 14, and after 28 days of SPD use.
Pilot Results: 27 patients (19 female and 8 male; age 57.1 ± 12.8, BMI 29.0 ± 8.1) were recruited. At baseline mean N-
Hoarseness
GSSIQ was 50.1 ± 22.4 and mean RSI of 29.6 ± 7.7. Repeated measure analysis showed that subjects' total N-
GSSIQ scores decreased by an average of 19.1 (p = 0.0004) points by two weeks and 26.5 points by 4 weeks
(p b 0.0001). RSI decreased an average of 5.3 points by 2 weeks (p = 0.0425) and an average of 14.0 points by
4 weeks (p b 0.0001).
Conclusions: In patients with LPR, SPD treatment significantly improves self-reported symptoms of nocturnal re-
flux as well as symptoms specific to LPR. These results support the therapeutic efficacy of a SPD for patients with
LPR.
© 2017 Elsevier Inc. All rights reserved.

1. Introduction
Laryngopharyngeal reflux (LPR) represents a unique clinical chal-
lenge for physicians treating the upper aerodigestive tract. LPR is de-
fined as reflux of gastric contents causing inflammation of the larynx
[1]. 10% of patients seen in otolaryngologist offices have been observed
to show symptoms of LPR [2] and as many as 50% of patients
complaining of hoarseness show clinical signs of LPR [3]. LPR has been
Abbreviations: LPR, laryngopharyngeal reflux; N-GSSIQ, Nocturnal Gastroesophageal
Reflux Symptoms Severity and Impact Questionnaire; RSI, Reflux Symptoms Index
questionnaire; SPD, sleep positioning device.
☆ Level of Evidence: 2 – Prospective Cohort Study.Financial disclosure/conflict of inter-
est: No author has any financial support or other conflict of interest to disclose. This re-
search was conducted without financial support from outside organizations. Sleep
positioning devices donated by Amenity Health, Inc.
⁎ Corresponding author.
E-mail address: tiernew@ccf.org (W.S. Tierney).
associated with patient discomfort and hoarseness in the short term
[2] and advanced and morbid disease if left untreated [4]. Heteroge-
neous symptomology and clinical presentation makes diagnosis of LPR
challenging [4] and no simple universal treatment for LPR currently ex-
ists. A combination of behavioral modifications and medical manage-
ment is the mainstay of current clinical treatment [5,6]. Behavioral
modifications recommended to patients include avoidance of chocolate,
fatty foods, acidic foods, spices, caffeine, and alcohol and lifestyle chang-
es such as elevation of the head of the bed, avoiding meals before sleep,
and rigorous adherence to scheduled medical dosing. Medical treat-
ment relies largely on proton pump inhibitor medications (PPIs) with
possible adjuvant use of H2-blockers, prokinetic agents, and mucosal
coating agents [6]. While a 90-day trial of PPIs has been shown to be a
cost-effective initial approach to LPR [7,8], it has also been shown that
behavioral changes, usually recommended concurrently, represent an
independently significant variable in patient response to treatment
[9]. Given expected variation in individual subject behaviors and

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Fig. 1. Diagram of Study Sleep Positioning Device. The sleep positioning device (Medcline;
Amenity Health, Inc., San Diego, CA) is designed to reduce nocturnal reflux episodes and
esophageal acid exposure. Consisting of an inclined base assembly combined with a
body pillow, it is designed to elevate the head/torso, while maintaining a recumbent
left-side down position.
adherence to medical regimens it is unsurprising that assessing the effi-
cacy of treatments has been difficult [10], and that many patients con-
tinue to have symptoms of LPR even after treatment by medical
professionals.
Nocturnal reflux is commonly observed in LPR patients [1] and pH
measurement of the oropharynx has been shown to be more acidic dur-
ing sleep [11]. Nocturnal reflux symptoms are also common among pa-
tients with gastroesophageal reflux disease (GERD). In this patient
group, the use of an incline wedge pillow or head-of-bed elevation has
been shown to reduce esophageal acid exposure by 10–52% [12–15].
Subjects who were placed at an incline and maintained in the left lateral
recumbent position showed a reduction in nocturnal acid reflux by 71%
[16–19]. Recently, it was demonstrated in healthy volunteers that the
use of a sleep positioning device (SPD; Medcline Reflux System, Ameni-
ty Health, Inc. San Diego, CA; Fig. 1) which maintains this left lateral re-
cumbent position on a 30 degree incline, decreased esophageal acid
exposure by 87%, when compared to sleeping with an incline wedge pil-
low only [20]. In addition, this SPD has been shown to improve symp-
toms of nocturnal GERD [21] (unpublished data from our institution).
Because of the success this non-invasive treatment method has shown
in nocturnal GERD patients, we hypothesized that it might also aid
laryngopharyngeal reflux patients without posing significant risk or
substantially inconveniencing patients.
Table 1
RSI and N-GSSIQ Scores by Time Point.
RSI total score (mean ± SD; range 0 to 45)
Total RSI proportion improved (% improved from baseline)
N-GSSIQ total score (mean ± SD; range 0 to 95)
Nocturnal symptoms (range 0 to 65)
Morning impact (range 0 to 10)
Concern about reflux (range 0 to 20)
Total N-GSSIQ proportion improved (% improved from baseline)
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2. Methods
To test this hypothesis we designed a prospective cohort study to
compare pre-treatment baseline symptoms of LPR to symptoms after
2 and 4 weeks of SPD therapy. After receiving approval from the Institu-
tional Review Board we enrolled 33 subjects selected from a consecu-
tive group of patients seen in the office by investigators. Inclusion
criteria were as follows; 1) diagnosis of LPR confirmed by one of the
study investigators, 2) current complaint of LPR symptoms, 3) adult pa-
tients, and 4) willing and able to use the sleep positioning device for at
least 6 h nightly for 4 weeks following study enrollment. The diagnosis
of LPR was arrived upon based on patient history, symptomatology, and
a minimum Reflux Symptoms Index score of 13. Laryngoscopic findings
were used to support these data but, based on previous research find-
ings, were not used as an inclusion criteria [22]. This diagnostic ap-
proach was used in the absence of a widely accepted approach to LPR
diagnoses [23,24]. Oropharyngeal pH monitoring was not conducted
as part of the diagnosis used in this study based on previous research
that has illustrated an uncertain relationship between LPR symptoms
to pH probe measurements [25]. We excluded subjects who 1) lacked
the physical or cognitive capacity to use the SPD, 2) were diagnosed
with a neoplastic disease of the aerodigestive tract, or 3) had undergone
previous radiation therapy to the head and neck. We delayed subject
enrollment if they had changed their reflux medications within the
4 weeks preceding baseline, and upon enrollment all subjects were
instructed to delay any changes in their medical therapy for LPR or
GERD until completion of the study.
Demographic and morphometric data were collected for all subjects
along from the electronic medical record (EMR). Current medications
and lifestyle interventions for LPR or other reflux diseases were also re-
corded from the EMR and confirmed verbally with subjects both at
baseline and at study completion. Primary outcomes for this research
were the Reflux Symptoms Index (RSI) [26] and Nocturnal GERD Symp-
tom Severity and Impact Questionnaire (N-GSSIQ) [27]. These are two
previously validated surveys that assess the symptoms of LPR and Noc-
turnal GERD respectively. The RSI consists of 9 questions scored from 0 to
5 with higher scores representing more severe symptomology. The N-
GSSIQ consists of 20 questions divided into 3 subscores. 13 questions
are scored from 0 to 5 and assess nocturnal reflux symptoms, 2 questions
are scored from 0 to 5 and assess the impact of reflux in the morning after
awakening from sleep, and 5 questions scored from 0 to 4 assess the
subject's concern or anxiety caused by their reflux symptoms. Higher
scores on the N-GSSIQ also represent more severe symptoms. All surveys
were administered either via telephone by the investigators or using the
REDCap [28] electronic survey tool hosted by the Cleveland Clinic.
All subjects were given descriptions of SPD and its use during the
consent process. After informed consent was obtained, subjects were
given detailed counseling on appropriate use of the SPD. Study protocol
required that subjects sleep using the SPD for 28 consecutive nights and
for at least 6 h per night. Subjects were asked to report deviation from
this protocol to the study coordinator. The study device was then mailed
to subjects directly from the manufacturer. Subjects were administered
a baseline questionnaire to confirm demographic and medical data and
completed both the RSI and N-GSSIQ when enrolling in the study.
Baseline 14 nights 28 nights
29.6 ± 7.7 23.3 ± 13.0 15.4 ± 9.3
NA 64% 96%
50.1 ± 22.4 30.4 ± 12.2 24.3 ± 21.1
29.9 ± 16.0 15.1 ± 14.2 11.1 ± 14.0
6.7 ± 3.0 4.6 ± 3.4 3.8 ± 3.1
13.6 ± 5.0 10.7 ± 5.9 9.3 ± 6.1
NA 86% 96%
 W.S. Tierney et al. / American Journal of Otolaryngology–Head and Neck Medicine and Surgery 38 (2017) 603–607 605

Subjects completed the RSI and N-GSSIQ again after 14 nights of SPD use
and after 28 nights of SPD use. Because the RSI assesses patient percep-
tion of reflux symptoms over a on month period, we modified this ques-
tionnaire at the 14 day time point to instead address the 14 days
following initiation of SPD use. This change in timing was judged to
have minimal impact on questionnaire validity and was therefore not
re-validated using psychometric methodology. Data were stored using
the Cleveland Clinic secure REDCap database and de-identified before
use.
Descriptive statistics were calculated for all demographics and base-
line measurements. Repeated measure analysis was completed to com-
pare each of the time points to one another. A calculation of the change
in both survey measures after 14 and 28 days was also conducted and
proportions of subjects benefitting from treatment were calculated. An
alpha level of 0.05 was considered significant. Statistical analyses were
Fig. 2. Average RSI Score by Time Point. Average reflux symptom index (RSI) questionnaire
conducted using SAS 9.3 (SAS Institute, Cary, NC) and JMP Pro 12.1
scores at each time point assessed. Maximum score 45. Minimum 0. Normal controls score
(SAS Institute, Cary, NC). between 0 and 13.

3. Results 4. Discussion

3.1. Subject characteristics
Of the 33 subjects consented to this research, 6 withdrew from the
study. 1 was lost to follow-up, 1 unenrolled from the study for an unre-
lated medical reason, 1 unenrolled from the study voluntarily for non-
medical reasons, and 3 were unable to tolerate SPD use beyond the
first 3 nights based on the size of the device in relation to their beds
and sleeping partners. Statistical analyses excluded all subjects who
did not begin SPD use. The subject population was predominantly fe-
male (70%) with an average BMI of 29.0 ± 8.1 (range 17.9–46.0) and av-
erage age of 57.1 ± 12.8 (range 24–85). 67% (18/27) of subjects used PPI
medications during this study. 2 subjects changed their reflux medica-
tion regimens during the study with both reducing their medication
after beginning use of the SPD. No subject increased pharmaceutical
dosage or added new medical therapy for reflux disease during the
study.
3.2. Average survey scores
Table 1 contains average values of RSI and N-GSSIQ instruments and
all subscores. Both RSI (Fig. 2) and N-GSSIQ (Fig. 3) decreased from
baseline to 14 night time point and further improved at the 28 night
time point in the majority of subjects. Additionally, all N-GSSIQ
subscores decreased at each time point. 64% of subjects reported im-
proved symptoms of LPR on the RSI after 14 nights and 96% reported im-
provement after 28 nights. 86% of subjects reported improvement in
nocturnal reflux on the N-GSSIQ after 14 nights and 96% reported im-
provement after 28 nights. When compared using paired t-testing
both RSI and N-GSSIQ differed significantly from baseline after 14 nights
of therapy (p-values 0.04 and 0.0003) and after 28 nights (both p-values
b 0.0001).
This study shows that LPR symptoms are significantly decreased in
subjects who added SPD therapy to their existing medical and behavior-
al regimens. The dramatic reduction in both validated survey instru-
ments utilized in this research illustrates a previously unreported
efficacy of SPD therapy for LPR. This improvement was statistically sig-
nificant after 14 nights and showed additional improvement after 28
nights. Furthermore, by 28 nights of therapy 96% of subjects experi-
enced a subjective improvement in their symptoms as measured by
each instrument. Additionally, significant decreases in all three
subscores of the N-GSSIQ (nighttime reflux symptoms, morning impact
of reflux, and patient concern over reflux) were significantly decreased
after 28 nights of SPD therapy. SPD treatment yielded improvement in
symptoms of LPR and nocturnal reflux disease including the anxiety in-
duced by the physical symptoms of this disease. Combined with the
non-invasive nature of the therapeutic modality, these results support
the addition of a SPD to the therapeutic regimen for LPR patients who
continue to experience symptoms despite initial medical treatment.
Moreover, this study showed improvement regardless of concurrent
therapeutic measures and also supports the use of SPDs for LPR patients
unwilling or unable to pursue pharmaceutical treatment options.
While the findings in this initial study strongly support the use of
SPDs to treat LPR, it is important to recognize several limitations of
this research. Firstly, the study design uses only internal controls for
each subject. The lack of an external control forces us to consider that
Hawthorne effect and/or selection bias may impact these data. Addi-
tionally, this research used only self-reported data to qualify symptoms

3.3. Repeated measure analysis

Table 2 contains the repeated measure findings of this study. The de-
crease from baseline in both RSI (Fig. 2) and N-GSSIQ (Fig. 3) total scores
was statistically significant after both 14 and 28 nights of therapy. All N-
GSSIQ subscores also decreased significantly from baseline at 14 nights
and 28 nights. The decrease in RSI from 14 nights of therapy to 28 nights
of therapy was significant as was the nocturnal symptoms subscore of
the N-GSSIQ. Total N-GSSIQ, the morning symptoms subscore, and the
concern subscore decreased during the period between our 14 nights Fig. 3. Average N-GSSIQ Score by Time Point. Average Nocturnal GERD Symptom Severity
and 28 nights time point, but this decrease did not reach statistical and Impact Questionnaire (N-GSSIQ) questionnaire scores at each time point assessed.
significance. Maximum score 95. Minimum 0.

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Table 2
Repeated measure analysis.
14 nights - baseline
RSI total (mean change ± SE) −5.3 ± 2.5
N-GSSIQ total score (mean change ± SE) −19.1 ± 4.5
Nocturnal symptoms −13.9 ± 3.2
Morning impact −2.0 ± 0.6
Concern about reflux −3.3 ± 1.3
of subjects because of the cost and discomfort of pH monitoring proto-
cols. Future research will be required to assess the impact of SPD thera-
py on oropharyngeal acidity and randomized study design should be
considered to conclusively characterize subject response to the inter-
vention. The inclusion of the RSI instrument in our selection criteria
also deserves comment because there remains debate over whether
this instrument may represent all laryngeal symptoms versus only
those due to reflux. Our institution uses the RSI to aid in diagnosis of
subjects with LPR and we believe that its use, in conjunction with clini-
cal findings and subject symptoms as a diagnostic tool, can aid in iden-
tifying subjects with LPR. Finally, by modifying the RSI to inquire about
symptomology “in the last 14 days” instead of “during the last month”
for our 14 day timepoint questionnaire there is the possibility that this
instrument is no longer valid. No psychometric validation was under-
taken specific to this altered-timepoint RSI because the change was
judged to have minimal impact on validity. The 28 day time point rep-
resents the results of a validated questionnaire and shows symptom re-
duction. It is the opinion of the authors that, despite these limitations,
the results of the current study are impactful enough to merit both fu-
ture research of SPD therapy for LPR and the clinical use of SPDs in pa-
tients suffering from LPR symptoms.
The greatest question that remains unanswered by this current
study is how much of the observed improvement in reflux symptoms
represents a true lessening of disease state versus a placebo effect ac-
companying the obvious SPD treatment may add bias to these data. In-
clined sleep positioning has been proven to decrease acid reflux in
subjects [12,13]. However placebo has also been shown to improve
symptoms in 40% of patients with reflux-related chronic laryngitis
[29]. It is likely that placebo effect has some impact on the degree of im-
provement observed with SPD use. However, without a realistic way to
blind subjects to their use of an SPD this possibility of placebo effect is
difficult to address methodologically. Additionally the strength of the
results in this study, with nearly all of our subjects showing symptom-
atic improvement, suggests a true therapeutic value to SPD use in addi-
tion to possible placebo effect. Even with the assumption that some of
the improvement observed is due to placebo effect the inherent safety
of SPDs when compared to first-line therapies, such as PPIs [30], justify
the use of these devices if they offer benefit to patients.
Several additional aspects of this study merit comment. Firstly, all
subjects were asked to maintain their reflux management throughout
the study and only subjects with no reflux medical management or sta-
ble medical regimens were enrolled in the study. The study was de-
signed to assess the impact of SPD therapy on subjects without
requiring standardized medical regimens or wash-out periods. In future
studies, multivariable modeling should be employed to assess whether
stable PPI use modifies the effect of SPDs on LPR symptoms. The sample
analyzed in this research was insufficient to address this question. This
study demonstrates that the vast majority of subjects experience symp-
tomatic relief with SPD therapy regardless of heterogeneous pre-
existing therapeutic regimens. Secondly, it is important to recognize
that of our 33 enrolled subjects only 27 began the therapeutic period
of this study. 3 subjects discontinued participation before SPD delivery
and 3 subjects (10% of the remaining 30) received the SPD and deter-
mined that the size of the device made it impractical for their use.
When reviewing SPD use, the provider should consider discussing the
size of the SPD with the patient to ensure that they have realistic
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p-Value 28 nights - baseline p-value 28 nights–14 nights p-Value
*0.0425 −14.0 ± 2.1 * b 0.0001 −8.7 ± 2.7 *0.0039
*0.0004 −26.5 ± 3.7 * b 0.0001 −7.4 ± 3.8 0.0646
*0.0002 −18.9 ± 2.7 * b 0.0001 −5.0 ± 2.3 *0.0413
*0.0022 −3.0 ± 0.6 *0.0001 −1.0 ± 0.8 0.2078
*0.0223 −4.6 ± 1.0 *0.0002 −1.4 ± 1.3 0.3086
expectations when the device arrives. Subjects in our study were
counseled on the specifics of the device but many were still surprised
by the size of the SPD when it arrived. In centers considering wide-
spread SPD use demonstration models may be the most effective meth-
od of educating subjects on the specifics of the device. Finally, subjects
reported some difficulty adhering to the instructions to sleep on the
SPD in the left lateral recumbent position for as long as possible each
night. Many subjects stated that they would awaken in a different posi-
tion or having moved off of the SPD. This study did not control for this
aspect of SPD use or variability in subject experience using the device.
Some subjects may experience reduced benefit from these devices
based on variability in sleep patterns. Pre-treatment counseling of pa-
tients should include a discussion of possible therapeutic failure with
moving off of the device as one possible cause.
5. Conclusions
Maintaining subjects at a 30-degree incline in the left lateral recum-
bent position overnight using a sleep positioning device significantly
decreases self-reported symptoms of laryngopharyngeal reflux. This im-
provement in symptoms was seen in 96% of subjects and represents
both a statistically and clinically significant improvement. Further stud-
ies will be required to assess the effect of SPDs on the pathophysiology
of LPR and to investigate the utility of SPDs in a randomized and more
regulated setting. Because of the significant benefit seen by subjects in
this study, and based on the non-invasive nature of SPD therapy, this
study justifies the use of SPDs in the treatment of LPR by clinicians
and researchers alike.
Acknowledgements
The authors would like to acknowledge the contributions of our sub-
jects, the administrative support of Heather Karn and the Cleveland
Clinic Head and Neck Institute staff, and Amenity Health Inc. for their
donation of the study device to our research.
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