Reducing Cardiovascular Disease Risk Through Treatment of Obstructive Sleep Apnea (U34)

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Purpose. The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) solicits three-year Clinical Trials Planning Grant Cooperative Agreement (U34) applications from institutions or organizations for pilot studies evaluating the treatment of obstructive sleep apnea (OSA) using positive airway pressure (PAP). The purposes of these studies are twofold. First, the studies should be designed to provide information regarding feasibility of long-term (12 to 18 months) PAP treatment of OSA in patients at risk of CVD. Second, the studies should provide data regarding the effects of PAP on surrogate markers of cardiovascular risk. Outcomes relevant for this FOA are broad and include a range of feasibility metrics (recruitment, retention, randomization, dose of PAP treatment, and design of control groups) and adherence outcomes (measures of patient acceptance of, satisfaction with, and adherence to PAP treatment); sympathetic nervous system hyperactivity; vascular dysfunction; inflammatory markers; platelet aggregation; and neuroendocrine and metabolic function. Populations that are at high risk for cardiovascular disease with established OSA and no prior history of PAP treatment will be the central focus of this initiative. Specific goals are to establish feasibility of long-term PAP treatment in high-risk individuals, to evaluate the potential for such treatment to produce changes in cardiovascular disease risk profiles, and to identify feasibility of study design strategies for future event-driven Phase III clinical trials.

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