Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00070681 |
| Other study ID # |
158 |
| Secondary ID |
R01HL070848 |
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
October 6, 2003 |
| Last updated |
July 28, 2016 |
| Start date |
September 2003 |
| Est. completion date |
June 2007 |
Study information
| Verified date |
April 2009 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To determine the effects of sleep disorders on cardiovascular function and disease in older
men.
Description:
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been archived for use in future studies of importance to the health of older men.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.
