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Sleep Apnea in a Non-Clinical Population

Primary Purpose

Lung Diseases, Sleep Apnea Syndromes, Obesity

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 Lung Diseases

Eligibility Criteria

30 Years - 60 Years (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
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005551
    Brief Title
    Sleep Apnea in a Non-Clinical Population
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    August 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2002 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To investigate the causes, consequences and quantitation of sleep disordered breathing (SDB).
    Detailed Description
    BACKGROUND: The study utilized an extremely rich source of data collected on the Wisconsin Sleep Cohort, one of the largest cohort studies of SDB and one with the longest periods of follow-up, to address a broad array of questions related to the pathogenesis and risk of SDB in the general community. The data-set was obtained between 1988 and 1998 in a population of 1400 workers age 30 to 60 years, including an overnight sleep polysomnographic in-lab study conducted on two occasions over an eight year period. The dataset contained a computerized analysis of over 300,000 apneas and hypopneas in this non-clinical population. Although strong associations have been demonstrated between sleep disordered breathing and cardiovascular diseases, much is not known regarding the mechanisms by which SDB produces blood pressure changes and increases morbidity. Further analysis of the polysomnography and blood pressure data could yield important insights into the physiologic events responsible for cardiovascular morbidity. Such information could then be used to develop diagnostic tests that identify those people at highest risk and thus who might especially benefit from intervention. This would be of potentially great public health importance, given the prevalence of SDB and the availability of treatments for SDB. DESIGN NARRATIVE: The investigators used the computerized database of the Wisconsin Sleep Cohort to answer the following specific questions. What were the physiologic characteristics of SDB events in the non-clinical population in terms of severity, high airway resistance, obstructive and central components and associated after-effects on EEG arousal and ventilatory overshoots? Did these important elements of the SDB event change as SDB progressed over time? Did the ventilatory or cardiovascular consequences of apnea or hypopnea and its immediate aftermath determine the likelihood of subsequent sleep-disordered breathing events? 2. What were the immediate and long-term cardiovascular consequences of sleep-disordered breathing events; what characteristics of these SDB events (such as oxygen desaturation, arousal, ventilatory overshoot airway resistance, etc.) determined the cardiovascular responses and consequences? 3. What was the effect of aging on SDB and its sequelae as studied in the truly healthy elderly? 4. What role did anatomical characteristics of the upper airway play in determining the frequency and severity and type of sleep-disordered breathing? Did these anatomical determinants differ in the general non-clinical population versus the obstructive sleep apnea (OSA) population? ... in the obese versus the non-obese? Organization responded that the study is non-FDAAA applicable and they do not accept transfer to their organization.

    6. Conditions and Keywords

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

    7. Study Design

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jerome Dempsey
    Organizational Affiliation
    University of Wisconsin, Madison

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12226022
    Citation
    Dempsey JA, Skatrud JB, Jacques AJ, Ewanowski SJ, Woodson BT, Hanson PR, Goodman B. Anatomic determinants of sleep-disordered breathing across the spectrum of clinical and nonclinical male subjects. Chest. 2002 Sep;122(3):840-51. doi: 10.1378/chest.122.3.840.
    Results Reference
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    Sleep Apnea in a Non-Clinical Population

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