Sleep Heart Health Study (SHHS) Data Coordinating Center

Sponsor

Johns Hopkins Bloomberg School of Public Health (Other)

Overall Status

Completed

CT.gov ID

NCT00005275

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

6,441

Enrollment

200

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Lung Diseases Sleep Apnea Syndromes Cardiovascular Diseases Heart Diseases Coronary Disease Cerebrovascular Accident Hypertension Myocardial Infarction

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

6441 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Study Start Date :

Sep 1, 1994

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Outcome Measures

Primary Outcome Measures

All-Cause Mortality [1998-2011]
Mortality subsequent to polysomnography performed in phase 1(1998-2000) for 6441 participants and in phase 2 (2001-2003) for 4381 participants. The latest follow-up data were collected from the parent cohorts in 2009-2011.

Other Outcome Measures

Prevalent cardiovascular events and stroke [1998-2011]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged 40 years and older
Able and willing to undergo a home polysomnogram

Exclusion Criteria:

Age < 40 years
Unwillingness, or social, physical or mental condition precluding a home polysomnogram

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: George O'Connor, MD, MS, Boston University
Principal Investigator: Naresh Punjabi, MD, PhD, Johns Hopkins University
Study Chair: Stuart Quan, MD, Harvard Medical School (HMS and HSDM)
Principal Investigator: David Rapoport, MD, NYU Langone Health
Principal Investigator: Susan Redline, MD, MPH, Brigham and Women's Hospital
Principal Investigator: Helaine Resnick, PhD, Leading Age
Principal Investigator: John Robbins, MD, University of California, Davis
Principal Investigator: Jonathan Samet, MD, MS, University of Southern California
Principal Investigator: Eyal Shahar, MD, MPH, University of Arizona
Principal Investigator: Marie Diener-West, PhD, Johns Hopkins University
Principal Investigator: Anne Newman, MD, MPH, University of Pittsburgh