Outcomes of Sleep Disorders in Older Men
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00070681|
Recruitment Status : Completed
First Posted : October 9, 2003
Last Update Posted : July 29, 2016
|Condition or disease||Intervention/treatment|
|Cardiovascular Diseases Heart Diseases Sleep Sleep Apnea Syndromes Neurologic Manifestations Osteoporosis Bone Diseases||Procedure: Polysomnography|
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 Blood, urine, and DNA specimens have been archived for use in future studies of importance to the health of older men.
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.
|Study Type :||Observational|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070681
|OverallOfficial:||Elizabeth Barrett-Connor||University of California, San Diego|
|OverallOfficial:||Jane Cauley||University of Pittsburgh|
|OverallOfficial:||Kristine Ensrud||University of Minnesota|
|OverallOfficial:||Cora Lewis||University of Alabama at Birmingham|
|OverallOfficial:||Eric Orwoll||Oregon Health and Science University|
|OverallOfficial:||Susan Redline||Case Western Reserve University|
|OverallOfficial:||Marcia Stefanick||Stanford University|
|OverallOfficial:||Katie Stone||University of California, San Francisco|