title: 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.
authors.affiliation: Stroke Program, University of Michigan, Ann Arbor, MI 48109-5855, USA. devinb@umich.edu
authors.forename: Devin L
authors.initials: DL
authors.lastname: Brown
authors.forename: Craig S
authors.initials: CS
authors.lastname: Anderson
authors.forename: Ronald D
authors.initials: RD
authors.lastname: Chervin
authors.forename: Clete A
authors.initials: CA
authors.lastname: Kushida
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Lewin
authors.forename: Beth A
authors.initials: BA
authors.lastname: Malow
authors.forename: Susan
authors.initials: S
authors.lastname: Redline
authors.forename: Edward B
authors.initials: EB
authors.lastname: Goldman
mesh_terms: D015897:Comorbidity; D045422:Continuous Positive Airway Pressure / Q000009:adverse effects / Q000941:ethics* / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D008297:Male; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D018570:Risk Assessment; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis / Q000628:therapy*; D017749:Total Quality Management; D014481:United States