跳至主要内容
临床试验/NCT00005275
NCT00005275已完成不适用

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 个研究点目标入组 6,441 人开始时间: 1994年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6,441
主要终点
All-Cause Mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 40 years and older
  • Able and willing to undergo a home polysomnogram

排除标准

  • Age < 40 years
  • Unwillingness, or social, physical or mental condition precluding a home polysomnogram

结局指标

主要结局

All-Cause Mortality

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie Diener-West

Professor

Johns Hopkins Bloomberg School of Public Health

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