Epidemiology of Sleep-Disordered Breathing in Adults - Full Text View

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:

MedlinePlus related topics: Mood Disorders Neurologic Diseases Sleep Disorders

U.S. FDA Resources

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

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

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Paul E Peppard, PhD

University of Wisconsin, Madison

More Information

Publications:

Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84.

Peppard PE, Young T, Palta M, Dempsey J, Skatrud J. Longitudinal study of moderate weight change and sleep-disordered breathing. JAMA. 2000 Dec 20;284(23):3015-21.

Young T, Finn L, Palta M. Chronic nasal congestion at night is a risk factor for snoring in a population-based cohort study. Arch Intern Med. 2001 Jun 25;161(12):1514-9.

Kadotani H, Kadotani T, Young T, Peppard PE, Finn L, Colrain IM, Murphy GM Jr, Mignot E. Association between apolipoprotein E epsilon4 and sleep-disordered breathing in adults. JAMA. 2001 Jun 13;285(22):2888-90.

Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. Review.

Punjabi NM, Bandeen-Roche K, Young T. Predictors of objective sleep tendency in the general population. Sleep. 2003 Sep15;26(6):678-83.

Young T, Rabago D, Zgierska A, Austin D, Laurel F. Objective and subjective sleep quality in premenopausal, perimenopausal, and postmenopausal women in the Wisconsin Sleep Cohort Study. Sleep. 2003 Sep15;26(6):667-72.

Lin L, Finn L, Zhang J, Young T, Mignot E. Angiotensin-converting enzyme, sleep-disordered breathing, and hypertension. Am J Respir Crit Care Med. 2004 Dec 15;170(12):1349-53. Epub 2004 Sep 24.

Peppard PE, Young T. Exercise and sleep-disordered breathing: an association independent of body habitus. Sleep. 2004 May 1;27(3):480-4.

Reichmuth KJ, Austin D, Skatrud JB, Young T. Association of Sleep Apnea and Type II Diabetes: A Population-based Study. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1590-5. Epub 2005 Sep 28.

Arzt M, Young T, Finn L, Skatrud JB, Bradley TD. Association of sleep-disordered breathing and the occurrence of stroke. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1447-51. Epub 2005 Sep 1.

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:

Respiratory Aspiration
Cardiovascular Diseases
Cerebrovascular Disorders
Nervous System Diseases
Sleep Apnea Syndromes
Sleep Disorders
Parasomnias
Mood Disorders
Respiration Disorders
Respiratory Tract Diseases

Signs and Symptoms, Respiratory
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Neurologic Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013