Epidemiology of Sleep-Disordered Breathing in Adults

Cardiovascular Disease Clinical Trial

Official title:

Epidemiology of Sleep-Disordered Breathing in Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00005557
• Other study ID #: 2012-0084
• Secondary ID: R01HL062252A5385
• Status: Active, not recruiting
• Start date: April 1999
• Est. completion date: April 2031

Study information

• Verified date: December 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1545
• Est. completion date: April 2031
• Est. primary completion date: April 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Cerebrovascular Disorders
• Mood Disorders
• Nervous System Diseases
• Neurologic Disorders
• Sleep Apnea Syndromes
• Sleep Disorders
• Sleep Wake Disorders

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. doi: 10.1164/rccm.200505-702OC. Epub 2005 Sep 1. — View Citation

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. doi: 10.1001/jama.285.22.2888. — View Citation

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. doi: 10.1164/rccm.200405-616OC. Epub 2004 Sep 24. — View Citation

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. doi: 10.1001/jama.284.23.3015. — View Citation

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. doi: 10.1056/NEJM200005113421901. — View Citation

Peppard PE, Young T. Exercise and sleep-disordered breathing: an association independent of body habitus. Sleep. 2004 May 1;27(3):480-4. doi: 10.1093/sleep/27.3.480. — View Citation

Punjabi NM, Bandeen-Roche K, Young T. Predictors of objective sleep tendency in the general population. Sleep. 2003 Sep;26(6):678-83. doi: 10.1093/sleep/26.6.678. — View Citation

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. doi: 10.1164/rccm.200504-637OC. Epub 2005 Sep 28. — View Citation

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. doi: 10.1001/archinte.161.12.1514. — View Citation

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. doi: 10.1164/rccm.2109080. — View Citation

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 Sep;26(6):667-72. doi: 10.1093/sleep/26.6.667. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cognitive outcomes	A variety of clinical and laboratory assessments measure cognitive outcomes.	measured at each study visit
Other	gait and balance	A series of walking tests are conducted.	measured at each study visit
Other	mental health outcomes	Questionnaires assess mood, depression, and anxiety.	evaluated at each study visit
Primary	sleep disorders and problems, cardiovascular and cognitive outcomes	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.	measured at each study visit
Secondary	cardiovascular outcomes	A variety of clinical and laboratory assessments measure cardiovascular outcomes.	measured at each study visit