Epidemiology of Sleep Disordered Breathing - SCOR in Cardiopulmonary Disorders of Sleep
| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | September 1988 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00005321 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Epidemiology of Sleep Disordered Breathing - SCOR in Cardiopulmonary Disorders of Sleep |
| Official Title ICMJE | Not Provided |
| Brief Summary | To address the public health importance of sleep disordered breathing and ultimately reduce morbidity through information gained from longitudinal, population-based, epidemiologic studies. |
| Detailed 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. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Natural History |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Not Provided |
| Study Population | Not Provided |
| Condition ICMJE |
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| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | Not Provided |
| Completion Date | August 1999 |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| Ages | Not Provided |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT00005321 |
| Other Study ID Numbers ICMJE | 4099 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | August 2000 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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