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Clinical Trials/NCT00005275
NCT00005275CompletedNot Applicable

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

Johns Hopkins Bloomberg School of Public Health0 sites6,441 target enrollmentStarted: September 1994Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
6,441
Primary Endpoint
All-Cause Mortality

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marie Diener-West

Professor

Johns Hopkins Bloomberg School of Public Health

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