Outcomes of Sleep Disorders in Older Men

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00070681
First received: October 6, 2003
Last updated: April 13, 2009
Last verified: April 2009

October 6, 2003
April 13, 2009
September 2003
June 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00070681 on ClinicalTrials.gov Archive Site
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Outcomes of Sleep Disorders in Older Men
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To determine the effects of sleep disorders on cardiovascular function and disease in older men.

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 Blood, urine, and DNA specimens have been archived for use in future studies of importance to the health of older men.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.

Observational
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  • Cardiovascular Diseases
  • Heart Diseases
  • Sleep
  • Sleep Apnea Syndromes
  • Neurologic Manifestations
  • Osteoporosis
  • Bone Diseases
Procedure: Polysomnography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2007
June 2007   (final data collection date for primary outcome measure)

No eligibility criteria

Male
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00070681
158
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Elizabeth Barrett-Connor University of California, San Diego
Investigator: Jane Cauley University of Pittsburgh
Investigator: Kristine Ensrud University of Minnesota - Clinical and Translational Science Institute
Investigator: Cora Lewis University of Alabama at Birmingham
Investigator: Eric Orwoll Oregon Health and Science University
Investigator: Susan Redline Case Western Reserve University
Investigator: Marcia Stefanick Stanford University
Investigator: Katie Stone University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP