Hypertension Clinical Trial
Official title:
The Sleep Heart Health Study (SHHS) Was a Multi-site Prospective Cohort Study to Investigate Obstructive Sleep Apnea (OSA) and Other Sleep-disordered Breathing (SDB) as Risk Factors for Cardiovascular Diseases and Hypertension
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.
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 are 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.
STATUS:
Over 80 manuscripts were published based on substudies and ancillary investigations. Three
primary outcomes papers were published in 2009 and 2010, based on follow-up as of 2006-2007.
The study was renewed several times to provide for continued data collection and follow-up,
including new polysomnograms. The formal funding for SHHS sites, which ended as of August
31, 2008, was followed by a one-year no- cost extension. Funding ceased for the
participating sites as of August 31, 2009, but the Data Coordinating Center and the PSG
Reading Center were granted additional no-cost extensions to support additional data
collection from the parent cohorts to obtain follow up through 2009, 2010 or 2011 (depending
on the cohort), on all-cause mortality, incident CVD, and stroke. The updated results were
presented in a session at the ATS 2012 meetings in San Francisco.
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