The Cleveland Family Study (CFS) is the largest family-based study of sleep apnea worldwide, consisting of 2,284 individuals (46% African American) from 361 families studied on up to 4 occasions over a period of 16 years. The study was begun in 1990 with the initial aims of quantifying the familial aggregation of sleep apnea. NIH renewals provided expansion of the original cohort (including increased minority recruitment) and longitudinal follow-up, with the last exam occurring in February 2006.
The Best Apnea Interventions for Research (BestAIR) study aimed to randomize approximately 180 patients with sleep apnea who had either established CVD or at least three CVD risk factors into a 12-mo, four-arm intervention study. All arms included nightly use of nasal dilator strips and conservative medical therapy (CMT) defined as education on healthy sleep and lifestyle. The two active arms were: (1) active CPAP delivered using standard support from a trained sleep technician; and (2) active CPAP enhanced by a behavioral promotion intervention delivered by a behavioral therapist. The two control arms were: (1) sham-CPAP; and (2) CMT alone. The primary physiological outcome was change in mean 24-h systolic blood pressure. Process measures were recruitment yields, retention rates, and CPAP adherence levels.
The Sleep Heart Health Study (SHHS) is a multi-center cohort study implemented by the National Heart Lung & Blood Institute to determine the cardiovascular and other consequences of sleep-disordered breathing. It tests whether sleep-related breathing is associated with an increased risk of coronary heart disease, stroke, all cause mortality, and hypertension. In all, 6,441 men and women aged 40 years and older were enrolled between November 1, 1995 and January 31, 1998. During exam cycle 3 (January 2001- June 2003), a second polysomnogram (SHHS-2) was obtained in 3,295 of the participants. Over 130 manuscripts have been published investigating predictors and outcomes of sleep disorders.