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Epidemiology of Sleep-Disordered Breathing in Adults
This study has been completed.
First Received: May 25, 2000   Last Updated: April 13, 2009   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005557
  Purpose

To characterize the natural history and biologic spectrum of sleep disordered breathing (SDB) and test hypotheses regarding SDB causes and consequences.


Condition Phase
Lung Diseases
Sleep Apnea Syndromes
Cerebrovascular Disorders
N/A

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources
Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 1999
Study Completion Date: March 2009
Primary Completion Date: March 2009 (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. The study of the Hmong is the first attempt at characterizing SDB in a population never studied, but at potentially high risk for unknown death during sleep. If successful, that is if the Hmong adults are in fact at higher risk for SDB, this would not only help in preventing early death in this group, but also help in the understanding of the pathophysiology of this disorder.

DESIGN NARRATIVE:

In this longitudinal study, follow-up polysomnography and other protocols are conducted on an established cohort of men and women, ages 35-70, currently enrolled in the Wisconsin Sleep Cohort Study. The proposed follow-up studies will yield data spanning 5-15 years, with two to five data collection points. In addition, home polysomnography protocols will be conducted on Hmong adults. The study aims to : 1) describe with optimal parameters the natural history and biologic spectrum of SDB; 2) test the role of obesity and other risk factors in the occurrence and progression of SDB; 3) test the hypothesis that SDB has a causal role in the development and exacerbation of elevated blood pressure and other cardiovascular disease risk factors; 4) test the hypothesis that SDB causes behavioral morbidity, including extreme daytime sleepiness, cognitive impairment, motor vehicle accidents, and depression; 5) characterize SDB and other sleep disorders in Hmong, a minority population at high risk for sudden death during sleep.

Follow-up of the cohort continues through March, 2009 to investigate the role of SDB as a determinant and correlate of preclinical cardiovascular and cerebrovascular disease (CVD/stroke), incident CVD/stroke, mortality and in chronic daytime dysfunction. Changes in SDB occurrence and its effects with aging from middle to older age will also be investigated. To achieve these goals follow-up exams will conduct the following tests for preclinical CVD/stroke: 24 hour ambulatory blood pressure, ankle-brachial systolic blood pressure index, carotid intima-media thickness, exercise treadmill test, and ECG. Polysomnography will also be performed, in addition to the follow-up exams, on a subsample of 500 men and women who will transition from middle to older age (>60 years) .

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

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

Sponsors and Collaborators
Investigators
Investigator: Terry Young 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.

Study ID Numbers: 5102
Study First Received: May 25, 2000
Last Updated: April 13, 2009
ClinicalTrials.gov Identifier: NCT00005557     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Lung Diseases
Respiration Disorders
Vascular Diseases
Dyssomnias
Sleep Disorders
Central Nervous System Diseases
Brain Diseases
Cerebrovascular Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Disease
Apnea
Nervous System Diseases
Respiration Disorders
Vascular Diseases
Sleep Disorders
Dyssomnias
Central Nervous System Diseases
Brain Diseases
Cerebrovascular Disorders
Sleep Disorders, Intrinsic
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009