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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00005275 |
To test whether sleep-disordered breathing is associated with an increased risk of coronary heart disease, stroke, all-cause mortality, and hypertension. The multicenter, longitudinal study draws on existing, well-characterized, and established epidemiologic cohorts.
Condition | Phase |
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Lung Diseases Sleep Apnea Syndromes Cardiovascular Diseases Heart Diseases Coronary Disease Cerebrovascular Accident Hypertension Myocardial Infarction |
N/A |
Study Type: | Observational |
Study Start Date: | September 1994 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
BACKGROUND:
The study was motivated by the increasing recognition of the frequent occurrences of sleep-disordered breathing in the general population and mounting evidence that sleep-disordered breathing may increase risk for cardiovascular diseases, including coronary artery disease and stroke, and for hypertension, and may reduce quality of life generally. Many clinical questions remain unanswered concerning sleep-disordered breathing as well: for example, when, in the natural history of the disorder, intervention is warranted; and how to determine who is at risk so that recently developed treatments can be applied in a cost-effective manner.
The initiative was developed by the Pulmonary Diseases Advisory Committee, approved by the full Committee in February, 1993, and given concept clearance by the October, 1993 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in January, 1994.
DESIGN NARRATIVE:
The SHHS adds in-home polysomnography to the data collected in each of the cohorts under study. Using the Compumedics SleepWatch polysomnograph, a single over-night polysomnogram is obtained at home for the subjects; the montage includes oximetry, heart rate, chest wall and abdominal movement, nasal/oral airflow, body position, EEG, ECG, and chin EMG. In-home monitoring provides data on the occurrence of sleep-disordered breathing and on arousals.
Although the SHHS is a prospective cohort study, the cross-sectional findings will provide new information on patterns of sleep and sleep-disordered breathing in the general population. Consequently, initial analyses will be descriptive and will also address cross-sectional associations of sleep-disordered breathing with prevalent cardiovascular disease and quality of life and with risk factors for cardiovascular disease. Longitudinal analyses will address sleep-disordered breathing as a predictor of cardiovascular outcomes and change in blood pressure.
The extent of information available on key cardiovascular risk factors varies among the parent cohorts. Some additional data are collected on covariates at enrollment into the SHHS. However, the parent studies are the principal source of information on risk factors for cardiovascular disease in the participants. The cardiovascular outcomes for all sites include hospitalized acute myocardial infarction, nonfatal coronary heart disease, stroke, and death due to cardiovascular or cerebrovascular disease. Change in blood pressure and diagnosis of hypertension is considered, and all participants complete a standardized instrument on quality of life. The cardiovascular outcomes will be adjudicated by methods already in place for the ARIC, CHS, SHS, and Framingham Field Centers and by the CHS process for the New York and Tucson Field Centers. Ancillary studies address other outcomes, such as cognitive functioning, that cannot be considered in the full SHHS cohort.
Several substudies are underway, including ones on polysomnogram scoring reliability, cognitive function, 24 hour blood pressure monitoring, and urinary catecholamines. .
The study has been renewed several times to provide for continued data collection and follow-up, including new polysomnograms. The study ends in August 2008.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Investigator: | George O'Connor | Boston University |
Investigator: | Naresh Punjabi | Johns Hopkins University |
Investigator: | Stuart Quan | University of Arizona |
Investigator: | David Rapoport | New York University Medical Center |
Investigator: | Susan Redline | Case Western Reserve University |
Investigator: | Helaine Resnick | Missouri Breaks Research, Inc. |
Investigator: | John Robbins | University of California at Davis |
Investigator: | Jonathan Samet | Johns Hopkins University |
Investigator: | Eyal Shahar | University of Minnesota |
Investigator: | Patricia Wahl | University of Washington |
Study ID Numbers: | 1302 |
Study First Received: | May 25, 2000 |
Last Updated: | April 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00005275 History of Changes |
Health Authority: | United States: Federal Government |
Cerebral Infarction Myocardial Ischemia Sleep Disorders Arteriosclerosis Brain Diseases Cerebrovascular Disorders Sleep Disorders, Intrinsic Necrosis Respiratory Tract Diseases Brain Ischemia Myocardial Infarction Arterial Occlusive Diseases Sleep Apnea Syndromes Heart Diseases |
Apnea Stroke Respiration Disorders Vascular Diseases Central Nervous System Diseases Dyssomnias Ischemia Coronary Disease Lung Diseases Brain Infarction Infarction Coronary Artery Disease Hypertension |
Cerebral Infarction Myocardial Ischemia Sleep Disorders Arteriosclerosis Brain Diseases Cerebrovascular Disorders Sleep Disorders, Intrinsic Necrosis Pathologic Processes Respiratory Tract Diseases Syndrome Brain Ischemia Cardiovascular Diseases Myocardial Infarction Arterial Occlusive Diseases |
Sleep Apnea Syndromes Disease Heart Diseases Apnea Nervous System Diseases Stroke Respiration Disorders Vascular Diseases Central Nervous System Diseases Dyssomnias Ischemia Coronary Disease Lung Diseases Brain Infarction Infarction |