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

Brown DL, Anderson CS, Chervin RD, Kushida CA, Lewin DS, Malow BA, Redline S, Goldman EB
J Clin Sleep Med. 2011 7 (1): 103-8

PMID: 21344041 · PMCID: PMC3041615

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.

MeSH Terms (13)

Comorbidity Continuous Positive Airway Pressure Double-Blind Method Female Humans Informed Consent Male Patient Selection Randomized Controlled Trials as Topic Risk Assessment Sleep Apnea, Obstructive Total Quality Management United States

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