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Impact of Sleep Disordered Breathing in Older Adults

Primary Purpose

Cardiovascular Diseases, Hypertension, Depression

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
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

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    March 15, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005378
    Brief Title
    Impact of Sleep Disordered Breathing in Older Adults
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    November 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1994 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 1998 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To test the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression.
    Detailed Description
    BACKGROUND: The health impact of disordered breathing during sleep among middle-aged and older men and women in the general population had not been well studied, and the need for treating relatively mild degrees of sleep-disordered breathing was unknown in 1994. The study was the first population study which examined the effect of sleep-disordered breathing on these health outcomes. The study sought to establish the prevalence of clinically important sleep-disordered breathing among middle-aged and older men and women and to provide quantitative data to serve as the basis for selecting patients for screening and deciding which patients might benefit from therapeutic intervention. DESIGN NARRATIVE: The study evaluated the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression. The study used the Veterans Administration Normative Aging Study (NAS) population, which consisted of approximately 1,700 community-dwelling-men who returned for examination every three years. Respiratory function was assessed during sleep among these men and their wives using a validated method for home sleep monitoring. Blood pressure, health-related quality of life, and depression score were also assessed in the home. The potential associations of sleep-disordered breathing with hypertension, impaired health-related quality of life, and depression were evaluated, and the possibility that these relationships differed between men and women was examined. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Hypertension, Depression, Sleep Apnea Syndromes, Lung Diseases

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

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    Impact of Sleep Disordered Breathing in Older Adults

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