Randomized Controlled Trial Comparing Flexible and Continuous Positive Airway Pressure Delivery: Effects on Compliance, Objective and Subjective Sleepiness and Vigilance
Open accessAbstract
STUDY OBJECTIVES: Positive airway pressure (PAP) treatment for obstructive sleep apnea (OSA) can be limited by suboptimal compliance. C-Flex technology (Philips Respironics, PA, USA) reduces pressure during expiration, aiming to improve comfort and therefore compliance. This may be of particular relevance to patients requiring high pressures. Many studies thus far have suffered from design limitations and small sample sizes. This study aimed to compare compliance with C-Flex and CPAP, as well as analyzing objective and subjective sleepiness and vigilance. DESIGN: Three-month, double-blinded, parallel-arm randomized controlled trial. SETTING: A university-based sleep laboratory. PATIENTS: 76 consecutive patients with severe OSA (mean +/- SD AHI 60.2 +/- 32.9 events/hour, ESS 13.6 +/- 4.5/24, BMI 35.6 +/- 7.8 kg/m2), without significant cardiac, respiratory, psychiatric, or sleep comorbidities. INTERVENTIONS: Patients were randomized to C-Flex (dip level 2) or CPAP. MEASUREMENTS AND RESULTS: Patients underwent titration with C-Flex/CPAP (mean pressure 11.6 cm H2O). Modified maintenance of wakefulness tests (mod-MWT), psychomotor vigilance tasks (PVT) and questionnaires were administered at baseline and after one and 3 months. Median compliance was 5.51 and 5.89 h/night in the C-Flex and CPAP groups respectively (P = 0.82). There were no significant differences between groups in terms of PVT reaction time, subjective sleepiness, sleep quality, health-related quality of life, or treatment comfort. There was no significant difference between the groups regarding the change in mod-MWT sleep latency values. CONCLUSIONS: In patients with severe OSA both CPAP and C-Flex resulted in substantial improvements in sleepiness, vigilance, and quality of life. The use of C-Flex did not result in greater compliance, and neither treatment appeared superior.
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A meta-analysis of 5 RCTs demonstrated no clinically significant difference in self-reported sleepiness between participants on modified pressure profile PAP compared to standard PAP.
“A meta-analysis of 5 RCTs 188,236-239 demonstrated no clinically significant difference in self-reported sleepiness between participants on modified pressure profile PAP compared to standard PAP (see supplemental material, Figure S86).”
From Treatment of Adult Obstructive Sleep Apnea With Positive Airway Pressure: An American Academy of Sleep Medicine Systematic Review, Meta-Analysis, and GRADE Assessment (2019) · cites this paper as [236]
The Results (p. 4) report no significant difference between C-Flex and CPAP on post-treatment questionnaires, which assessed subjective sleepiness. This paper is one RCT, not the five-trial meta-analysis, and it does not establish the pooled finding or whether the pooled difference was clinically significant. (LLM, conf=0.86)
Experimental — accuracy not yet measuredOne study reporting global QOL using SF-36 MCS, PCS, and vitality scores found no significant difference in any of these measures.
“One study 236 reporting global QOL using SF-36 MCS, PCS, and vitality scores found no significant difference in any of these measures.”
From Treatment of Adult Obstructive Sleep Apnea With Positive Airway Pressure: An American Academy of Sleep Medicine Systematic Review, Meta-Analysis, and GRADE Assessment (2019) · cites this paper as [236]
The Materials and Methods (p. 2) specify SF-36's eight subscales as outcomes, and the Results (p. 4) report no significant posttreatment questionnaire-score differences between C-Flex and CPAP; the table on p. 5 includes vitality. Our copy does not report SF-36 MCS or PCS scores, so it does not establish the claim for those two measures. (LLM, conf=0.88)
Experimental — accuracy not yet measuredSeven RCTs investigated the use of modified pressure profile PAP to improve clinical outcomes and reduce side effects.
“A total of 7 RCTs investigated the use of modified pressure profile PAP to improve clinical outcomes and reduce side effects.188,[236][237][238][239][240][241]”
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- Authors
- Bakker, J., Campbell, A., & Neill, A.
- Affiliations
- University of Otago (NZ)
- Health New Zealand (NZ)
- Corresponding author
- Bakker, Jessie
- Venue
- Sleep
- Publisher
- Oxford University Press (OUP)
- Published
- 2010-04
- Volume
- 33
- Issue
- 4
- Pages
- 523-529
- ISSN
- 0161-8105 (ISSN-L)
- 1550-9109
- PMC
- PMC2849792
- OpenAlex
- W1608027688
- Semantic Scholar
- 47bde441f752e7b6f3e4c092e0af5faf5ae509dd
- Cited by
- 55
- References
- 50
- Citations by year
- 2026: 2 · 2024: 3 · 2022: 1 · 2021: 2 · 2020: 1 · 2019: 4 · 2018: 1 · 2017: 3 · 2016: 9 · 2015: 3 · 2014: 7 · 2013: 4 · 2012: 4
- FWCI
- 4.12
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- SLEEP (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
- Keywords
- obstructive sleep apnea, continuous positive airway pressure, CPAP adherence, sleepiness, sustained attention, maintenance of wakefulness test, psychomotor vigilance task, treatment comfort, health-related quality of life
- MeSH terms
- Adult, Aged, Arousal, Double-Blind Method, Equipment Design, Female, Follow-Up Studies, Humans, Male, Middle Aged, Patient Compliance, Psychomotor Performance, Quality of Life, Surveys and Questionnaires, Sleep, Sleep Apnea, Obstructive, Continuous Positive Airway Pressure
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