Randomized controlled trial comparing flexible and continuous positive airway pressure delivery: effects on compliance, objective and subjective sleepiness and vigilance.

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.