Sleep Heart Health Study (SHHS) Data Coordinating Center

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marie Diener-West, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00005275
First received: May 25, 2000
Last updated: May 19, 2013
Last verified: May 2013
  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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • All-Cause Mortality [ Time Frame: 1998-2011 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005275

Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
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 at 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, U01HL053941
Study First Received: May 25, 2000
Last Updated: May 19, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on April 16, 2014