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Epidemiology of Sleep Apnea Syndrome

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ClinicalTrials.gov Identifier: NCT00005286
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of New Mexico

Tracking Information
First Submitted Date May 25, 2000
First Posted Date May 26, 2000
Last Update Posted Date January 15, 2016
Study Start Date April 1986
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00005286 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiology of Sleep Apnea Syndrome
Official Title Not Provided
Brief Summary To define the prevalence of Sleep Apnea Syndrome (SAS) in a community-based sample of Hispanic adults.
Detailed Description

BACKGROUND:

The Sleep Apnea Syndrome consists of sleep-induced disturbances of breathing and breathing-induced disturbances of sleep. Symptoms of pathologic sleepiness and, less commonly, frequent awakenings and light sleep reflect the fragmentation of sleep by repeated respiration-related arousals. Snoring, intermittent choking, and nocturnal dyspnea reflect varying degrees of upper airway obstruction associated with Sleep Apnea Syndrome. Observations of breathing during sleep show varying combinations and degrees of periodic breathing, apneas, and hypoxemia. In more severe cases, cardiovascular complications, including systemic and pulmonary hypertension and cardiac arrhythmias, occur. The clinical spectrum thus varies from the asymptomatic patient, to one with chronic cardiac and respiratory failure who is at risk of sudden death. Most patients are disabled by varying degrees of pathologic sleepiness.

The rapid increase of clinical activity with the Sleep Apnea Syndrome created an urgent need for a more complete description of this condition. Clinical descriptions were derived from case series of severely afflicted patients. Limited epidemiologic data, however, indicated that symptoms and objective manifestations of Sleep Apnea Syndrome occurred commonly in the population. It was unknown whether subjects with these findings were unrecognized patients, premorbid individuals at risk, or normal subjects with no special impairments. There was a need to define the frequency of signs and symptoms of Sleep Apnea Syndrome in the general population, and to determine the health effects related to these findings.

DESIGN NARRATIVE:

Subjects were recruited from a previous survey, the Belen Health Study, conducted from July 1984 through November 1985. Based on the data of the earlier survey, 421 subjects were identified for recruitment and 275 actually participated. The Belen Health Study questionnaire included items directed at Sleep Apnea Syndrome. Subjects for the sleep study were selected based on responses to the initial questionnaire. For the sleep study, an additional questionnaire was used, as well as new techniques of home monitoring of breathing during sleep, and polysomnography to define the prevalence of symptoms and manifestations of Sleep Apnea Syndrome. An assessment of the health effect of Sleep Apnea Syndrome was made by reference to the demographic, socio-economic, and health data from the Belen Health Study. Diagnostic criteria and the utility of home monitors for clinical diagnosis were also determined.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Lung Diseases
  • Sleep Apnea Syndromes
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment Not Provided
Original Enrollment Not Provided
Study Completion Date March 1989
Primary Completion Date Not Provided
Eligibility Criteria No eligibility criteria
Sex/Gender
Sexes Eligible for Study: Male
Ages up to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00005286
Other Study ID Numbers 2007
R01HL034864 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor University of New Mexico
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators Not Provided
PRS Account University of New Mexico
Verification Date January 2016