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Epidemiology of Sleep-Disordered Breathing in Adults

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ClinicalTrials.gov Identifier: NCT00005557
Recruitment Status : Enrolling by invitation
First Posted : May 26, 2000
Last Update Posted : November 1, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
To characterize the natural history and biologic spectrum of sleep disordered breathing (SDB) and other sleep problems and disorders, and test hypotheses regarding the causes and consequences of SDB and other sleep problems and disorders.

Condition or disease
Sleep Disorders Cerebrovascular Disorders Cardiovascular Disease Neurologic Disorders Mood Disorders

Detailed Description:


Recent research has shown that sleep disordered breathing (SDB) is much more common than previously thought. While it is known that in clinic samples, SDB is associated with hypertension, cardiovascular disease and mortality, little is known about the natural history of this disorder, particularly in the general population, nor about the causal role of known risk factors. The knowledge obtained from the results of this study will help advance the field of sleep disorders medicine. Information about longitudinal effects and causal relationships may be applied to clinical situations, thus reducing the morbidity and mortality associated with this disorder.


In this longitudinal study, follow-up polysomnography and other protocols are conducted on an established cohort of men and women (age 30-60 years at the time of initial recruitment in 1989), currently enrolled in the Wisconsin Sleep Cohort Study. The study aims to : 1) describe the natural history of SDB across middle and older age; 2) investigate associations of SDB with early and intermediate markers of cardiovascular dysfunction, damage, and cardiovascular disease; 3) investigate the longitudinal association of SDB in accelerated cognitive decline; 4) investigate the association of SDB and adverse sleep characteristics with age-related risk factors and outcomes.

Study Type : Observational
Actual Enrollment : 1545 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Sleep-Disordered Breathing in Adults
Study Start Date : April 1999
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2023

Primary Outcome Measures :
  1. sleep disorders and problems, cardiovascular and cognitive outcomes [ Time Frame: measured at each study visit ]
    Overnight polysomnography is used to assess sleep pathology. Questionnaires are used to assess sleep habits. A variety of clinical and laboratory assessments measure cardiovascular and cognitive outcomes.

Secondary Outcome Measures :
  1. cardiovascular outcomes [ Time Frame: measured at each study visit ]
    A variety of clinical and laboratory assessments measure cardiovascular outcomes.

Other Outcome Measures:
  1. cognitive outcomes [ Time Frame: measured at each study visit ]
    A variety of clinical and laboratory assessments measure cognitive outcomes.

  2. gait and balance [ Time Frame: measured at each study visit ]
    A series of walking tests are conducted.

  3. mental health outcomes [ Time Frame: evaluated at each study visit ]
    Questionnaires assess mood, depression, and anxiety.

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
In 1988, employees of 4 Wisconsin state agencies, ages 30-60 years, were surveyed regarding sleep habits and problems by mail. From these data, a sampling frame was constructed and 2884 randomly-selected men and women (of 4896 survey respondents) were invited to participate in the WSC Study. Recruitment for baseline sleep studies occurred from 1989 to 2004.

Inclusion criteria:

  • Employee of one of the 4 Wisconsin state agencies
  • Age 30-60 in 1988

Exclusion criteria:

  • Current pregnancy
  • Unstable or decompensated cardiopulmonary disease
  • Airway cancer
  • Recent upper respiratory surgery

Information from the National Library of Medicine

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): NCT00005557

United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Paul E Peppard, PhD University of Wisconsin, Madison


Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00005557     History of Changes
Other Study ID Numbers: 2012-0084
R01HL062252 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Cardiovascular Diseases
Sleep Wake Disorders
Mood Disorders
Respiratory Aspiration
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Brain Diseases
Central Nervous System Diseases
Vascular Diseases