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

Devin Brown, Craig Anderson, Ronald Chervin, Clete Kushida, Daniel Lewin, Beth Malow, Susan Redline, Edward Goldman

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    19 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)103-108
    Number of pages6
    JournalJournal of Clinical Sleep Medicine
    Volume7
    Issue number1
    DOIs
    Publication statusPublished - 2011

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  • Cite this

    Brown, D., Anderson, C., Chervin, R., Kushida, C., Lewin, D., Malow, B., Redline, S., & Goldman, E. (2011). Ethical issues in the conduct of clinical trials in obstructive sleep apnea. Journal of Clinical Sleep Medicine, 7(1), 103-108. https://doi.org/10.5664/jcsm.28049