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.
AD - Stroke Program, University of Michigan, Ann Arbor, MI 48109-5855, USA. devinb@umich.edu AN - 21344041 BT - Journal of Clinical Sleep Medicine ET - 2011/02/24 LA - eng M1 - 1 N1 - Brown, Devin LAnderson, Craig SChervin, Ronald DKushida, Clete ALewin, Daniel SMalow, Beth ARedline, SusanGoldman, Edward BUnited StatesJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep MedicineJ Clin Sleep Med. 2011 Feb 15;7(1):103-8. N2 -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.
PY - 2011 SN - 1550-9397 (Electronic)1550-9389 (Linking) SP - 103 EP - 8 T2 - Journal of Clinical Sleep Medicine TI - Ethical issues in the conduct of clinical trials in obstructive sleep apnea VL - 7 ER -