Sleep Heart Health Study (SHHS) Data Coordinating Center
This study has been completed.
Sponsor:
Johns Hopkins Bloomberg School of Public Health
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
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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:
MedlinePlus related topics:
Coronary Artery Disease
Heart Attack
Heart Diseases
High Blood Pressure
Sleep Apnea
U.S. FDA Resources
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 May 22, 2013