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PEOPLE. PRODUCTS. PROGRAMS.SM
Comparison of CPAP vs. C-Flex™
for the Treatment of Obstructive Sleep Apnea
A Summary of Two Independent Studies

C-Flex therapy is defined as CPAP with the C-Flex therapy feature enabled.

during use. Richard Strobel. A typical complaint by those using conventional CPAP is that it is difficult to breathe out against continuous positive pressure. conventional continuous positive airway pressure (CPAP) adherence is known to be only 40% to 70%. The figure below shows a schematic representation of patient flow and the resulting pressure delivered with C-Flex. C-Flex. C-Flex therapy is titrated in the same way as conventional CPAP. WA. was developed to provide a base pressure to abolish pharyngeal collapse. C-Flex Description C-Flex represents a revolutionary new method for delivering positive airway pressure (PAP) for the treatment of obstructive sleep apnea (OSA). PA. providing optimal therapeutic support to the airway. C-Flex is designed to provide pressure relief during expiration. Inc. To establish the optimal C-Flex pressure. Comparison of CPAP vs. depending on the actual patient airflow. under the direction of principal investigator Dr. Prior to the end of expiration and start of each inspiration. while maintaining optimal pneumatic splinting for effective therapy. The first study was conducted at Lehigh Valley Hospital Sleep Disorder Center in Allentown. there is a return to the prescribed therapeutic CPAP pressure. . resulting in sleep fragmentation and occasional discontinuation of therapy. Expiratory pressure relief during exhalation is shown. as well as decrease the cumulative pressure during exhalation. This often results in short usage patterns and frequent awakenings. with the pressure returning to base pressure prior to the initiation of inspiration. C-Flex therapy allows for pressure reduction at the start of exhalation followed by a sinusoidal rise in pressure as exhalation ends. However. Two independent studies were performed by board certified sleep clinicians in AASM accredited sleep centers comparing C-Flex to CPAP. under the direction of principal investigator Dr. A novel positive pressure mode. 2 © 2003 Respironics. The sensation of being unable to fully exhale against CPAP or pressure intolerance is a frequent complaint of non-adherent patients. C-Flex technology monitors the patient’s airflow during expiration and reduces expiratory pressure proportional to expiratory flow. The second study was conducted at the Swedish Sleep Medicine Institute at Swedish Medical Center in Seattle. C-Flex™ for the Treatment of Obstructive Sleep Apnea Introduction Despite nearly 100% efficacy as a treatment for obstructive sleep apnea (OSA). The relief pressure varies on a breath-to-breath basis. Daniel Loube.

C-Flex levels 1 and 3. and 3 – maximum) were studied for equal time periods of 60 minutes in 30-minute increments. demonstrated statistically significant improvements. sleep efficiency (SE%). and 3. diagnosis of OSA/H by PSG and successful titration PSG for clinically effective CPAP within the past year. throat. arousal index (AI). neuro-muscular or muscular-skeletal). compared to CPAP. 3 . The analysis was done by the mixed models procedure in SAS. oxygen saturation (Sp02). All patients provided informed consent. Patient age and body mass index (BMI) were also evaluated. C-Flex produced similar or better AHI compared to that seen with CPAP. hospitalization within the past three months (for cardiac or pulmonary disease).g. were evaluated. if not more. and snore index (Snore).. The variables analyzed include apnea-hypopnea index (AHI). or nose surgery. effective as traditional CPAP.10. STUDY 1 – LEHIGH VALLEY HOSPITAL. The study population included 30 individuals on CPAP therapy for at least six months of clinically demonstrated successful therapy. Statistical Analysis CPAP followed by three levels of C-Flex therapy in two non-randomized rounds. or restrictive lung disorders (e. There was no statistically significant difference between CPAP and C-Flex for oxygen saturation or snore index. oxygen saturation (SpO2). Inclusion criteria were age ≥18 years. psychiatric disorders. arousal index (AI). ALLENTOWN. Exclusion criteria included inability to wear the mask. Parameters assessed include Apnea Hypopnea Index (AHI). Statistical significance was assessed at a P-value ≤ 0. Subjects underwent a single night of polysomnography (PSG) in a single-blind. 2 – moderate. 2. The C-Flex results were comparable to the CPAP results. CPAP and each of the three C-Flex comfort levels (1 – minimum. use of supplemental oxygen during sleep. and 2) the C-Flex therapy pressure profile minimizes sleep apnea and provides sleep quality that is equivalent to standard treatment. C-Flex therapy provided successful positive airway pressure therapy. non-randomized split format.Purpose The aim of these studies was to assess whether: 1) C-Flex is an effective method to treat adult OSA. sleep efficiency (SE%). tracheotomy. Summary of Results The data shows that C-Flex provides therapy that is as. © 2003 Respironics. and snoring index. CPAP was always given first followed by C-Flex levels 1. receiving CPAP and C-Flex therapy. upper airway. For arousal index. PA Methods The study was performed under an IRB approved protocol. as compared to conventional CPAP. resulting in eight segments. excessive arousals or sleep disturbance associated with other sleep problems. All three levels of C-Flex produced statistically significant improvement in sleep efficiency. Inc.

Inc.71 5.95 7.54 6.96 C-Flex 1 2. and Snore The following tables and graphs illustrate the descriptive statistics.61 6. SEI.05 C-Flex 2 2. Apnea Hypopnea Index (AHI) Therapy Mean SD CPAP 2. Descriptive Statistics for AHI.01 C-Flex 3 2. . AI.92 Oxygen Saturation (Sp02) Therapy Mean SD CPAP 93% 3% C-Flex 1 94% 3% C-Flex 2 93% 4% C-Flex 3 94% 3% 4 © 2003 Respironics. Sp02.

1493) and C-Flex 3 (P=0.11 C-Flex 2 0.30 These results indicate there is a statistically significant difference between CPAP and C-Flex levels 1 and 3 for AI.92 0.90 C-Flex 3 9.16 C-Flex 1 0.91 0.88 0.40 15. Inc. © 2003 Respironics.13 C-Flex 2 11. 5 .0054)].0648).32 14.17 Arousal Index (AI) Therapy Mean SD CPAP 16.13 C-Flex 3 0.14 19.50 10.Sleep Efficiency (SE) Therapy Mean SD CPAP 0.90 0.76 C-Flex 1 12. C-Flex 2 (P=0. The analysis of AI demonstrated significant improvements using C-Flex levels 1 and 3 compared to conventional CPAP [C-Flex 1 (P=0.

1318 and C-Flex 3 and CPAP. For sleep efficiency. although the comparison with C-Flex 2 and C-Flex 3 were close to significance (C-Flex 2 and CPAP.05 C-Flex 3 53. apnea/hypopnea index.5 102. there were statistically significant improvements seenat all three C-Flex comfort levels and. and oxygen saturation. 6 © 2003 Respironics. There were no statistically significant differences between CPAP and C-Flex for snore. Snore Therapy Mean SD CPAP 62.02 108.15 There were no statistically significant differences between CPAP and C-Flex for the snore analysis. for arousal index. . C-Flex is as equivalent or superior than CPAP in reducing sleep disordered breathing events and improving sleep efficiency in patients with obstructive sleep apnea/hypopnea syndrome. p = 0.1239).9 107. p = 0. Conclusion When compared to conventional CPAP. Inc.94 C-Flex 2 59.58 100. Based on this analysis. C-Flex at all three comfort levels is either equivalent to or superior than conventional CPAP.93 C-Flex 1 59. there were statistically significant improvements seen at C-Flex comfort levels 1 and 3 when compared to CPAP.

7) (± 21.4 10.8) (± 9. AI.0 (± 13. Prospective.4) SE 80. Baseline CPAP C-Flex 1 C-Flex 2 C-Flex 3 AHI 40.3) (± 17.7) (± 9.0) © 2003 Respironics.4 (± 13.9 92.4) (± 20.0) (± 23.4) (± 11. after subjects had signed informed consent.4 20.0) (± 18.5 4.7 94. Inc.6 6.2 19.STUDY 2 – SWEDISH MEDICAL CENTER.4) (± 9. WA Methods Study was performed under an IRB approved protocol.1 5. randomized double-blind study of 16 patients recently diagnosed with OSA who received a successful CPAP titration study.9) (± 9.5 15. Patients with other concomitant sleep disorders were excluded.2) (± 5. in-lab titration study during which CPAP and C-Flex therapy were compared. 7 .4) (± 8. Results were compared between conventional CPAP and C-Flex and pressure relief settings using ANOVA statistical methods and linear mixed effects. total arousal index (AI). OSA patients had an apnea/hypopnea index (AHI) > 10 events/hr and did not have predominately REM-related or position dependent OSA. C-Flex expiratory pressure relief was applied at various settings and each was compared to CPAP with respect to the AHI.3 5.2 92. or sleep efficiency for OSA patients using CPAP or C-Flex at each of the pressure relief settings. sleep efficiency (SE) and other measurements derived from nocturnal polysomnography.1 88.8 (± 26. Summary of Results These data demonstrate that there is no statistically significant difference in the AHI. These patients underwent a split-night.0) AI 36. SEATTLE.

Customer Service • 1-800-345-6443 • 724-387-4000 Respironics Europe: +33-(0)1-55-60-19-80 www. C-Flex therapy allows for pressure reduction during exhalation without recurrence of obstructive respiratory events during sleep. for AHI. Inc. and its affiliates. 1016631 KW 9/29/03 .respironics. sleep efficiency. Decreased mean mask pressure with the same therapeutic effect suggests possible advantage to adult OSA patients who are non-compliant with CPAP because of expiratory pressure intolerance. or arousal index.com Respironics Asia Pacific: +852-234-342-18 ©2003 Respironics.Conclusion There is no statistically significant difference between CPAP and C-Flex at any of the pressure relief settings. C-Flex is as effective as CPAP in abolishing obstructive respiratory events and has the same immediate effect on sleep.