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Sleep Heart Health Study (SHHS) Data Coordinating Center (SHHS)

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ClinicalTrials.gov Identifier: NCT00005275
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : May 21, 2013
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Marie Diener-West, Johns Hopkins Bloomberg School of Public Health

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
Lung Diseases Sleep Apnea Syndromes Cardiovascular Diseases Heart Diseases Coronary Disease Cerebrovascular Accident Hypertension Myocardial Infarction

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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 : September 1994
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. All-Cause Mortality [ Time Frame: 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:
  1. Prevalent cardiovascular events and stroke [ Time Frame: 1998-2011 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants in SHHS were recruited from NHLBI cohort studies already in progress. Parent cohort studies and recruitment targets for these cohorts were as follows:

  • Atherosclerosis Risk in Communities Study (ARIC) - 1,750 participants
  • Cardiovascular Health Study (CHS) - 1,350 participants
  • Framingham Heart Study (FHS) - 1,000 participants
  • Strong Heart Study (SHS) - 600 participants
  • New York Hypertension Cohorts - 1,000 participants
  • Tucson Epidemiologic Study of Airways Obstructive Diseases and the Health and Environment Study - 900 participants

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005275

Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Heart, Lung, and Blood Institute (NHLBI)
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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
Additional Information:
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Marie Diener-West, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00005275    
Other Study ID Numbers: 1302
U01HL053941-14 ( U.S. NIH Grant/Contract )
U01HL053941 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Lung Diseases
Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Coronary Disease
Vascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Myocardial Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases