Longitudinal comparison study of pressure relief (C-Flex) vs. CPAP in OSA patients.
BACKGROUND
Continuous positive airway pressure (CPAP) devices with the option of flexible pressure delivery (e.g., C-Flex) are thought to provide an improved degree of comfort and result in better therapeutic adherence while maintaining standard CPAP efficacy. The purpose of this study was to compare adherence and subjective measures of comfort between C-Flex and CPAP treatment.


METHODS
The study was an international, multisite, single-blinded study with participants randomized to either C-Flex or CPAP. Participants completed subjective measures of sleepiness and comfort at baseline, and at 30-, 90-, and 180-day follow-ups. Additionally, compliance data were downloaded from the device at each follow-up. Repeated measures analysis of variance was used to assess the effects of treatment.


RESULTS
There were 138 men and 46 women (average age of 48 +/- 9.2, average Epworth Sleepiness Scale score of 14.9 +/- 3.6, and average diagnostic apnea/hypopnea index (AHI) of 51.9 +/- 27.7). C-Flex and CPAP groups were comparable on baseline measures, achieved comparable AHI on titration, and had comparable PAP pressure requirements. C-Flex users had comparable average hours of use per night and total nights of use across the study, but had a trend (p < .07) toward achieving greater total hours of utilization. While both groups had comparable decreases in sleepiness, C-Flex users reported on visual analog scales greater comfort (64.3 vs. 57.4; p = .01).


CONCLUSIONS
The results of this study demonstrated that C-Flex has comparable resolution of respiratory indices and adherence. Furthermore, C-Flex users reported greater mask comfort.
The University of North Texas, Denton, TX, USA.
Diana C
DC
Dolan
Renata
R
Okonkwo
Florian
F
Gfullner
J Randall
JR
Hansbrough
Richard J
RJ
Strobel
Leon
L
Rosenthal
D000328:Adult; D000368:Aged; D045422:Continuous Positive Airway Pressure / Q000379:methods*; D006970:Disorders of Excessive Somnolence / Q000175:diagnosis / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007040:Hypoventilation; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D017286:Polysomnography; D011312:Pressure; D011446:Prospective Studies; D016037:Single-Blind Method; D020181:Sleep Apnea, Obstructive / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D011795:Surveys and Questionnaires