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.
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 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.
The Hispanic Community Health Study / Study of Latinos (HCHS/SOL) is a multi-center epidemiologic study in Hispanic/Latino populations to determine the role of acculturation in the prevalence and development of disease, and to identify risk factors playing a protective or harmful role in Hispanics/Latinos. The study is sponsored by the National Heart, Lung, and Blood Institute (NHLBI) and six other institutes, centers, and offices of the National Institutes of Health (NIH) contributed to the first phase of the project.
Multi-Ethnic Study of Atherosclerosis (MESA), is an NHLBI-sponsored 6-center collaborative longitudinal investigation of factors associated with the development of subclinical cardiovascular disease and the progression of subclinical to clinical cardiovascular disease in 6,814 black, white, Hispanic, and Chinese-American men and women initially ages 45-84 at baseline in 2000-2002. There have been four follow-up exams to date, in the years 2003-2004, 2004-2005, 2005-2007, and 2010-2011. Between 2010-2012, 2,237 participants also were enrolled in a Sleep Exam (MESA Sleep) which included full overnight unattended polysomnography, 7-day wrist-worn actigraphy, and a sleep questionnaire. The objectives of the sleep study are to understand how variations in sleep and sleep disorders vary across gender and ethnic groups and relate to measures of subclinical atherosclerosis.
The Home Positive Airway Pressure (HomePAP) study was a multisite, nonblinded, randomized controlled trial that enrolled 373 patients at seven American Academy of Sleep Medicine (AASM)-accredited academic sleep centers with a high pretest probability of moderate to severe OSA (based on a clinical algorithm). Eligible subjects were evaluated in clinic and randomized to one of two management pathways: 1) laboratory-based and 2) home-based. All subjects with an AHI ≥ 15 who underwent a successful CPAP titration study were offered CPAP therapy. Subjects were re-evaluated in clinic after 1- and 3-month follow-up periods.