TY - JOUR
T1 - Ethical issues in the conduct of clinical trials in obstructive sleep apnea
AU - Brown, Devin
AU - Anderson, Craig
AU - Chervin, Ronald
AU - Kushida, Clete
AU - Lewin, Daniel
AU - Malow, Beth
AU - Redline, Susan
AU - Goldman, Edward
PY - 2011
Y1 - 2011
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.
AB - 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.
KW - Clinical trials
KW - Ethics
KW - Obstructive sleep apnea
UR - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3041615/pdf/jcsm.7.1.103.pdf
UR - http://www.scopus.com/inward/record.url?scp=79958015343&partnerID=8YFLogxK
U2 - 10.5664/jcsm.28049
DO - 10.5664/jcsm.28049
M3 - Review article
SN - 1550-9389
VL - 7
SP - 103
EP - 108
JO - Journal of Clinical Sleep Medicine
JF - Journal of Clinical Sleep Medicine
IS - 1
ER -
