The role of sham continuous positive airway pressure as a placebo in controlled trials: Best Apnea Interventions for Research Trial.

ABSTRACT: The main objective of this study was to evaluate the role of sham continuous positive airway pressure (CPAP) compared to conservative medical therapy (CMT) as a control arm in the Best Apnea Interventions for Research (BestAIR) study by assessing differences in subjectively and objectively measured outcomes, adverse events, adherence, and retention rates. BestAIR is a clinical trial aimed to identify important design features for future randomized controlled trials of CPAP. Participants with obstructive sleep apnea were randomized to one of four groups; two control arms (CMT, sham-CPAP) and two active CPAP arms (with and without behavioral interventions). Blood pressure and health-related quality of life outcomes were assessed at baseline, 6 and 12 months. Study outcomes, retention, and ad

SUBMITTER: Reid ML 

PROVIDER: S-EPMC7182666 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature