Sleep Apnea in a Non-Clinical Population

May 12, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To investigate the causes, consequences and quantitation of sleep disordered breathing (SDB).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Jerome Dempsey, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1999

Study Completion (ACTUAL)

March 1, 2002

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (ESTIMATE)

May 26, 2000

Study Record Updates

Last Update Posted (ESTIMATE)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

August 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5095
  • R03HL062686 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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