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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Marie Diener-West, Johns Hopkins Bloomberg School of Public Health

Tracking Information
First Submitted Date May 25, 2000
First Posted Date May 26, 2000
Last Update Posted Date May 21, 2013
Study Start Date September 1994
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 19, 2013)
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00005275 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures
 (submitted: May 19, 2013)
Prevalent cardiovascular events and stroke [ Time Frame: 1998-2011 ]
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sleep Heart Health Study (SHHS) Data Coordinating Center
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
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Lung Diseases
  • Sleep Apnea Syndromes
  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Disease
  • Cerebrovascular Accident
  • Hypertension
  • Myocardial Infarction
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 19, 2013)
6441
Original Enrollment Not Provided
Actual Study Completion Date May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00005275
Other Study ID Numbers 1302
U01HL053941-14 ( U.S. NIH Grant/Contract )
U01HL053941 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Marie Diener-West, Johns Hopkins Bloomberg School of Public Health
Study Sponsor Johns Hopkins Bloomberg School of Public Health
Collaborators 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
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date May 2013