A randomized, double-blind clinical trial comparing continuous positive airway pressure with a novel bilevel pressure system for treatment of obstructive sleep apnea syndrome.

STUDY OBJECTIVES: To obtain efficacy, objective compliance, and self-assessment data from obstructive sleep apnea syndrome (OSAS) patients treated with continuous positive airway pressure (CPAP) or a novel bilevel (NBL) therapy.

DESIGN: Randomized, controlled, double-blind trial.

SETTING: Home treatment after diagnosis and titration by split-night polysomnography (PSG) in a sleep laboratory.

PATIENTS: Twenty-seven adults (22 men) newly referred for suspected OSAS but without concomitant medical or sleep disorders.

INTERVENTIONS: If the subject's apnea-hypopnea index was greater than 10 and less than 100, the CPAP was titrated during PSG and then followed by NBL titration. Treatment was randomly and blindly set to either CPAP or NBL mode for 1 month.

MEASUREMENTS & RESULTS: There were no significant baseline group differences in age, body mass index, apnea-hypopnea index (mean +/- SD, CPAP group vs NBL group of 46.1 +/- 23.1/hour vs 41.8 +/- 25.8), CPAP requirement, or scores on the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire. Treatment with CPAP and NBL equivalently reduced the apnea-hypopnea index during the laboratory titration (7.6 +/- 11.9/hour vs. 3.7 +/- 4.4, respectively). At 1 month, there were no significant group compliance differences as determined by percentage of nights with at least 4 hours of use (CPAP, 80.5 +/- 24 vs NBL, 77.6 +/- 24.8) and hours of use per night (CPAP, 5.6 +/- 1.4 hours/night vs NBL, 5.6 +/- 1.7). Similar improvements were seen in scores on the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire.

CONCLUSIONS: The NBL appeared to be as effective as CPAP for the treatment of OSAS but offered no advantages in patients receiving first-time therapy for OSAS.