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NCT00005296 Clinical Trial

Sleep Apnea: Age Effects On Prevalence and Natural History

Lung Diseases Clinical Trial

Official title:
Sleep Apnea: Age Effects On Prevalence and Natural History

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00005296
Other study ID # 2019
Secondary ID R01HL040916
Status Completed
Phase
First received
Last updated
Start date January 1990
Est. completion date January 18, 1995

Study information
Verified date April 2019
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To identify the prevalence of sleep apnea in men and its relationship to age, assess the natural history of the disorder, and predict those men at risk.

Description:

BACKGROUND:

Sleep apnea is potentially a life-threatening disorder commonly associated with the aging process. Often sleep apnea is accompanied by considerable morbidity for both physical and mental health; the associated excessive daytime sleepiness, cardiovascular abnormalities, and cognitive impairment impact greatly on daytime functioning. In 1990, the prevalence of sleep apnea in the general population was undetermined, and there was much speculation regarding its natural history.

DESIGN NARRATIVE:

For the prevalence study, 4,364 randomly-sampled men selected from the general population and stratified by age were evaluated for risk factors for sleep apnea. A total of 741 men found to be at risk were evaluated in the sleep laboratory to determine the degree, if any, of sleep apnea or sleep disordered breathing. Prior to recording subjects in the sleep laboratory, a thorough history was obtained from each subject and a physical examination completed. All men entering into the first four years of the prevalence portion of the study who were found to have sleep apnea or sleep disordered breathing were reevaluated yearly over a five year period in the natural history part of the study. The natural history portion also included 150 men previously studied in the sleep laboratory for apnea but who were not part of the random sample of 4,000 and who were not part of the prevalence study.

Recruitment information / eligibility
Status Completed
Enrollment 741
Est. completion date January 18, 1995
Est. primary completion date January 18, 1995
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 100 Years
Eligibility stratified random sample based on risk severity for sleep disordered breathing based on phone interview

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Milton S. Hershey Medical Center National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (1)

Bixler EO, Vgontzas AN, Ten Have T, Tyson K, Kales A. Effects of age on sleep apnea in men: I. Prevalence and severity. Am J Respir Crit Care Med. 1998 Jan;157(1):144-8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary sleep disordered breathing Apnea/hypopnea index immediately upon time of recording
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