Epidemiology of Sleep-Disordered Breathing in Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00005557
First received: May 25, 2000
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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
Sleep Disorders
Cerebrovascular Disorders
Cardiovascular Disease
Neurologic Disorders
Mood Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Sleep-Disordered Breathing in Adults

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • sleep disorders and problems, cardiovascular and cognitive outcomes [ Time Frame: measured at each study visit ] [ Designated as safety issue: No ]
    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:
  • cardiovascular outcomes [ Time Frame: measured at each study visit ] [ Designated as safety issue: No ]
    A variety of clinical and laboratory assessments measure cardiovascular outcomes.


Other Outcome Measures:
  • cognitive outcomes [ Time Frame: measured at each study visit ] [ Designated as safety issue: No ]
    A variety of clinical and laboratory assessments measure cognitive outcomes.

  • gait and balance [ Time Frame: measured at each study visit ] [ Designated as safety issue: No ]
    A series of walking tests are conducted.

  • mental health outcomes [ Time Frame: evaluated at each study visit ] [ Designated as safety issue: No ]
    Questionnaires assess mood, depression, and anxiety.


Enrollment: 1545
Study Start Date: April 1999
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005557

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Paul E Peppard, PhD University of Wisconsin, Madison
  More Information

Publications:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00005557     History of Changes
Other Study ID Numbers: 2012-0084, R01HL062252
Study First Received: May 25, 2000
Last Updated: December 11, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 20, 2014