Ethical issues in the conduct of clinical trials in obstructive sleep apnea

Abstract

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.

Randy Clare

Randy Clare

Randy Clare brings to The Sleep and Respiratory Scholar more than 25 years of extensive knowledge and experience in the sleep and pulmonary function field. He has held numerous management positions throughout his career and has demonstrated a unique view of the alternate care diagnostic and therapy model. He is considered by many an expert in the use of a Sleep Bruxism Monitor in a dental office. He is also very involved with physician office spirometry for the early detection of COPD and Asthma

Mr. Clare’s extensive sleep industry experience assists Sleep Scholar in providing current, relevant, data-proven information on sleep diagnostics and sleep therapies that are effective for the treatment of sleep disorders.

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