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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005321
Other study ID # 4099
Secondary ID
Status Completed
Phase N/A
First received May 25, 2000
Last updated July 11, 2016
Start date September 1988
Est. completion date August 1999

Study information

Verified date August 2000
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To address the public health importance of sleep disordered breathing and ultimately reduce morbidity through information gained from longitudinal, population-based, epidemiologic studies.


Description:

BACKGROUND:

The investigators have shown that undiagnosed sleep disordered breathing is prevalent for both men and women throughout the range of middle age; multidisciplinary research findings suggest that untreated sleep disordered breathing may lead to significant behavioral and cardiovascular morbidity. The relative risks are of direct application to public health estimates of: How much behavioral and cardiovascular morbidity would be eliminated if prevalence of untreated sleep disordered breathing were significantly reduced? How much reduction in sleep disordered breathing prevalence could be achieved by eliminating the modifiable etiologic factors? Should high risk groups be targeted for early detection of risk factor reduction programs?

DESIGN NARRATIVE:

The study quantified the etiologic role of hypothesized risk factors for sleep disordered breathing, described progression of the pathophysiologic process, and tested causal hypotheses of adverse health outcomes. The study was conducted on a unique, established cohort of over 800 subjects, representative of middle-aged employed adults. Extensive baseline polysomnographic and other data were available on the established cohort of 800 subjects; additional cohorts of 50 perimenopausal women and 200 older adults were added for maximum study power. The research resulted in longitudinal data, over a 5-9 year period, on multiple parameters of sleep, breathing, risk factors and outcomes. The independent relative risks were calculated with multivariate techniques to express the temporal relationships for sleep disordered breathing etiologic factors and for consequences of sleep disordered breathing.

The study was renewed in 1993 and used longitudinal studies to focus on specific questions of greatest relevance to public health, namely: the roles of aging and menopause in the development of sleep-disordered breathing and the effect of sleep disordered breathing on hypersomnolence and systemic hypertension.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date August 1999
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (4)

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. — View Citation

Wetter DW, Young TB. The relation between cigarette smoking and sleep disturbance. Prev Med. 1994 May;23(3):328-34. — View Citation

Young T, Blustein J, Finn L, Palta M. Sleep-disordered breathing and motor vehicle accidents in a population-based sample of employed adults. Sleep. 1997 Aug;20(8):608-13. — View Citation

Young T, Hutton R, Finn L, Badr S, Palta M. The gender bias in sleep apnea diagnosis. Are women missed because they have different symptoms? Arch Intern Med. 1996 Nov 25;156(21):2445-51. — View Citation

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