The National Heart, Lung, and Blood Institute (NHLBI) has announced an initiative to conduct proof-of-concept Phase II clinical trials that test a novel intervention for a lung disease or a cardiopulmonary disorder from sleep that have the potential to significantly change clinical management. Double-blinded placebo-controlled designs are encouraged. It is anticipated that appropriate physiological or biochemical endpoints rather than clinical endpoints will be used given the limitations of this initiative.

This initiative may be of interest to sleep/circadian researchers collaborating with cardiovascular researchers, and experienced clinical trial specialists to develop a well focused and feasible multidisciplinary effort.

For additional information on the scope of the initiative, research examples, and program specifics please see the full text of the announcement on the NIH Web site.