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.
The CHAT is a multi-center, single-blind, randomized, controlled trial designed to test whether after a 7-month observation period, children, ages 5 to 9.9 years, with mild to moderate obstructive sleep apnea randomized to early adenotonsillectomy (eAT) will show greater levels of neurocognitive functioning, specifically in the attention-executive functioning domain, than children randomized to watchful waiting plus supportive care (WWSC). Other outcomes assessed included other indices of neurocognitive functioning (learning and memory, information processing, etc.), physical growth, blood pressure, metabolic profile, symptoms and quality of life. Physiological measures of sleep were assessed at baseline and at 7-months with standardized full polysomnography with central scoring at the Brigham and Women’s Sleep Reading Center. In total, 1,447 children had screening polysomnographs and 464 were randomized to treatment.
HeartBEAT is a Phase II randomized controlled trial, 4 center trial that evaluates the effects of supplemental nocturnal oxygen or Positive Airway Pressure (PAP) therapy, compared to optimal medical preventive therapy, over a 3 month intervention period in patients with cardiovascular disease (CVD) or CVD risk factors and moderate to severe obstructive sleep apnea (apnea hypopnea index 15 to 50). The study’s primary outcome is 24 hour blood pressure profile.
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 multi-center Study of Osteoporotic Fractures (SOF) has 16 years of prospective data about osteoporosis that has served as the basis for many findings about osteoporosis and aging in women >= age 65. In addition to adjudication of fractures, SOF has tracked cases of incident breast cancer, stroke, and total and cause-specific mortality. The data include serial measures of bone mineral density, measurements of sex and calcitropic hormones, tests of strength and function, cognitive exams, use of medication, health habits and much more.