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临床试验/NCT00070681
NCT00070681已完成不适用

Outcomes of Sleep Disorders in Older Men

National Heart, Lung, and Blood Institute (NHLBI)0 个研究点开始时间: 2003年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成

研究概览

简要总结

To determine the effects of sleep disorders on cardiovascular function and disease in older men.

详细描述

BACKGROUND:

It is estimated that over 50 percent of adults aged 65 and older report some sleep disruption, while about 20 percent suffer from chronic insomnia. Obstructive sleep apnea, a major cause of daytime drowsiness, occurs in an estimated 20-60 percent of older people, depending on the definition used and the specific population being studied. Despite the high prevalence of sleep disorders in the elderly, there have been relatively few studies focused on the consequences. Most studies have been limited by cross-sectional design, small sample size, or lack of comprehensive and objective assessment of sleep. The study, Outcomes of Sleep Disorders in Older Men, will take advantage of the established cohort that has been recruited for the Osteoporotic Fractures in Men (MrOS) Study (5U01AR045647-Dr. Eric Orwoll, PI). MrOS, a 7-year study that began in July 1999, is a multi-center prospective study of approximately 6,000 men aged 65 and older. During the MrOS baseline visit, a broad variety of measurements were collected, including body composition and body fat distribution by dual energy X-ray absorptiometry (DEXA) and quantitative computed tomography, bone density, anthropometry, performance-based tests of strength and balance, medical history, medication use, smoking and alcohol use, and other parameters. Blood, urine, and DNA specimens have been archived for use in future studies of importance to the health of older men.

DESIGN NARRATIVE:

In a subcohort of 3,000 MrOS participants, comprehensive and accurate assessments of sleep will be added using in-home polysomnography, wrist actigraphy, questionnaires and other measures; and prospective adjudication of cardiovascular disease (CVD) events, to the extensive measures that have already been performed or planned in the MrOS cohort study. These new measures will enable testing of several important hypotheses: 1) to characterize the associations between sleep disruption and subsequent CVD events during 3.5 years of follow-up, 2) to determine if sleep disturbances are associated with an increased risk of total and cause-specific mortality in older men, 3) to test whether sleep disturbances are associated with increased risk of falls and decreased physical function, 4) to test whether sleep disturbances are associated with impaired cognitive function in older men, and 5) to test whether sleep disorders are associated with bone density and fracture risk in older men. The bank of MrOS specimens will be supplemented to allow for testing of future hypotheses concerning the role of sleep in the development of age-related diseases and conditions.

研究设计

研究类型
Observational

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

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