Outcomes of Sleep Disorders in Older Men
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Sleep
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Polysomnography
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00070681
First Posted
October 6, 2003
Last Updated
July 28, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00070681
Brief Title
Outcomes of Sleep Disorders in Older Men
Study Type
Observational
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To determine the effects of sleep disorders on cardiovascular function and disease in older men.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Sleep, Sleep Apnea Syndromes, Neurologic Manifestations, Osteoporosis, Bone Diseases
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Polysomnography
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Barrett-Connor
Organizational Affiliation
University of California, San Diego
First Name & Middle Initial & Last Name & Degree
Jane Cauley
Organizational Affiliation
University of Pittsburgh
First Name & Middle Initial & Last Name & Degree
Kristine Ensrud
Organizational Affiliation
University of Minnesota
First Name & Middle Initial & Last Name & Degree
Cora Lewis
Organizational Affiliation
University of Alabama at Birmingham
First Name & Middle Initial & Last Name & Degree
Eric Orwoll
Organizational Affiliation
Oregon Health and Science University
First Name & Middle Initial & Last Name & Degree
Susan Redline
Organizational Affiliation
Case Western Reserve University
First Name & Middle Initial & Last Name & Degree
Marcia Stefanick
Organizational Affiliation
Stanford University
First Name & Middle Initial & Last Name & Degree
Katie Stone
Organizational Affiliation
University of California, San Francisco
12. IPD Sharing Statement
Citations:
PubMed Identifier
36244405
Citation
Shahrbabaki SS, Linz D, Redline S, Stone K, Ensrud K, Baumert M. Sleep Arousal-Related Ventricular Repolarization Lability Is Associated With Cardiovascular Mortality in Older Community-Dwelling Men. Chest. 2023 Feb;163(2):419-432. doi: 10.1016/j.chest.2022.09.043. Epub 2022 Oct 13.
Results Reference
derived
PubMed Identifier
31585012
Citation
May AM, May RD, Bena J, Wang L, Monahan K, Stone KL, Barrett-Connor E, Koo BB, Winkelman JW, Redline S, Mittleman MA, Mehra R; Osteoporotic Fractures in Men (MrOS) Study Group. Individual periodic limb movements with arousal are temporally associated with nonsustained ventricular tachycardia: a case-crossover analysis. Sleep. 2019 Oct 21;42(11):zsz165. doi: 10.1093/sleep/zsz165.
Results Reference
derived
PubMed Identifier
30590586
Citation
Baumert M, Immanuel SA, Stone KL, Litwack Harrison S, Redline S, Mariani S, Sanders P, McEvoy RD, Linz D. Composition of nocturnal hypoxaemic burden and its prognostic value for cardiovascular mortality in older community-dwelling men. Eur Heart J. 2020 Jan 21;41(4):533-541. doi: 10.1093/eurheartj/ehy838.
Results Reference
derived
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Outcomes of Sleep Disorders in Older Men
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