01079nas a2200217 4500000000100000008004100001100001500042700001500057700001300072700001300085700001500098700001500113700001300128700001900141245008000160250001500240300001000255490000600265520054400271020004600815 2011 d1 aChervin R.1 aKushida C.1 aLewin D.1 aMalow B.1 aRedline S.1 aGoldman E.1 aBrown D.1 aAnderson Craig00aEthical issues in the conduct of clinical trials in obstructive sleep apnea a2011/02/24 a103-80 v73 a
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.
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