Study objectives: We hypothesized that early intervention with an auto bilevel device would improve treatment adherence compared to CPAP among OSA patients with a poor initial experience with lab-based CPAP titration.
Methods: Patients with a poor initial CPAP experience were recruited for this parallel group, randomized, double-blind, controlled pilot study. After an in-lab titration, patients were randomized with either an auto-bilevel device or CPAP. Treatment adherence and functioning were assessed at 90 days.
Results: We enrolled 51 subjects, with 47 completing the protocol. Groups were equally matched for gender, age, education, and OSA severity. There was no significant difference in the proportion of compliant subjects (≥ 4 h/night) between the auto bilevel and CPAP groups (62% vs. 54%; p = 0.624) after 90 days of use. Functional outcomes significantly improved in both groups during treatment use (p < 0.001) but did not differ between groups.
Conclusions: There was no statistically significant difference in adherence between the auto bilevel and CPAP groups in this study. Patients with a poor initial CPAP exposure may still achieve an acceptable long-term clinical outcome. Both groups demonstrated comparably significant improvements in functional outcomes, sleepiness, and fatigue complaints over the treatment period. CLINICAL TRIALS INFORMATION: NCT00635206 ClinicalTrials.gov
Keywords: Treatment compliance; bilevel positive airway pressure; continuous positive airway pressure; lung; obstructive sleep apnea.