Data Coordinating Center for Sleep Heart Health

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DESCRIPTION (provided by applicant): This application presents a plan for continuing the Coordinating Center (CC) for the Sleep Heart Health Study (SHHS) within the Center for Clinical Trials and Departments of Epidemiology and Biostatistics of the Johns Hopkins Bloomberg School of Public Health. The SHHS was started in 1994 as a multicenter prospective cohort study of the cardiovascular consequences of sleep-disordered breathing (SDB). A cohort of 6441 persons, drawn from various ongoing studies was enrolled and had an overnight in-home polysomnogram (PSG); 3295 participants had a second PSG 5 years later. Funds are being requested to continue follow-up of the SHHS cohort in a companion application: "The Sleep Heart Health Study (SHHS)." The CC was housed at the University of Washington School of Public Health for the initial five years of the SHHS and was then transferred to Johns Hopkins for the subsequent five years of funding. During the first four years of CC operations at Johns Hopkins, the SHHS data base was migrated to the CCT, a data system and forms were put in place in support of the second wave of polysomnograms (PSGs), data analysis was carried out, and other administration functions were maintained, including committee operations. During the four years of funding requested with this application, the focus of the SHHS will be on completing follow-up of the cohort and carrying out analyses to address the study's original hypotheses related to sleep-disordered breathing (SDB) and risk for cardiovascular disease, including hypertension and acute cardiovascular events and stroke. Accordingly, during the requested four years of support, the CC will carry out the following functions: 1) continue to maintain the SHHS data base, adding follow-up information as it is developed by the SHHS field sites and the Adjudication Committee; 2) provide central analyses of the SHHS data, particularly for the longitudinal analyses focusing on the study's primary hypotheses; 3) coordinate operations of the SHHS committees including the Steering Committee and its subcommittees, the Presentation and Publications Subcommittee, and the Morbidity and Mortality Subcommittee; 4) maintain the SHHS website and respond to requests for data access and sharing; 5) schedule and staff the required annual Observational Safety and Monitoring Board (OSMB) meetings; and 6) coordinate the closing down of the study at the end of the SHHS.