Dronabinol Efficacy for Sleep Apnea Treatment

Safety analysis was performed on participants who received at least one dose of dronabinol. The efficacy evaluable population included all participants completing at least 7 days of treatment without non-compliance, including at least one on-treatment repeat PSG. Non-compliance was failure to: return for study-visits, administer or log >50% of study drug, or return study drug blistercards/unused drugs. The primary efficacy measurement was within-participant change in AHI (ΔAHI) from baseline to day 21 of treatment. Other efficacy measures included ΔAHI stratified by sleep stage, body position, first-half vs. second half of the night, and oximetry-based indices and sleep architecture. The distribution of all primary and secondary efficacy measures was checked using Anderson–Darling normality tests. The primary and secondary efficacy measures were analyzed with paired two-sided t-tests. The independent effects of the dose of dronabinol and baseline disease severity (AHI) on primary efficacy measure were examined with ANCOVA. The stratified analyses were defined a priori and no adjustment for multiple comparisons was employed for these exploratory analyses. All analyses were performed using STATA 12 and a p-value of <0.05 was considered significant.