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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005275
First Posted: May 26, 2000
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Marie Diener-West, Johns Hopkins Bloomberg School of Public Health
  Purpose
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
Lung Diseases Sleep Apnea Syndromes Cardiovascular Diseases Heart Diseases Coronary Disease Cerebrovascular Accident Hypertension Myocardial Infarction

Study Type: Observational
Study Design: 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

Further study details as provided by Marie Diener-West, Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • 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:
  • Prevalent cardiovascular events and stroke [ Time Frame: 1998-2011 ]

Enrollment: 6441
Study Start Date: September 1994
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
Criteria

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
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)
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
Principal Investigator: David Rapoport, MD New York University School of Medicine
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
  More Information

Additional Information:
Publications:

Responsible Party: Marie Diener-West, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00005275     History of Changes
Other Study ID Numbers: 1302
U01HL053941-14 ( U.S. NIH Grant/Contract )
U01HL053941 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: March 17, 2014
Last Verified: May 2013

Additional relevant MeSH terms:
Hypertension
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Sleep Apnea Syndromes
Lung Diseases
Coronary Disease
Coronary Artery Disease
Stroke
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases