Ethical issues in the conduct of clinical trials in obstructive sleep apnea
Scientifically rigorous clinical trials are needed to test continuous positive airway pressure’s (CPAP) effect on important clinical endpoints known to be associated with obstructive sleep apnea, such as myocardial infarction, cardiac arrhythmias, stroke, mortality, seizures, and cognitive function. In this “Special Article,” we review the regulatory and ethical issues that surround the design and conduct of CPAP trials, including selection of the appropriate control condition, exclusion criteria, and follow-up duration. CITATION: Brown DL; Anderson CS; Chervin RD; Kushida CA; Lewin DS; Malow BA; Redline S; Goldman EB. Ethical issues in the conduct of clinical trials in obstructive sleep apnea. J Clin Sleep Med 2011;7(1):103-108.