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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

65 Years - 100 Years (Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 6, 2003
    Last Updated
    July 28, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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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