Epidemiology of Sleep Apnea Syndrome

• ClinicalTrials.gov Identifier: NCT00005286
• Recruitment Status: Completed
• First Posted: May 26, 2000
• Last Update Posted: January 15, 2016
• Sponsor: University of New Mexico
• 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 *

• Wiggins RV, Schmidt-Nowara WW. Treatment of the obstructive sleep apnea syndrome. West J Med. 1987 Nov;147(5):561-8. Review.
• Schmidt-Nowara WW, Coultas DB, Wiggins CL, Skipper BE, Samet JM: Prevalence and Correlates of Snoring in Adult Populations. Proceedings of the First International Congress of Chronic Rhonchopathy, Paris, July 1987 . 1988.
• Wiggins CL, Schmidt-Nowara WW, Coultas DB, Samet JM. Comparison of self- and spouse reports of snoring and other symptoms associated with sleep apnea syndrome. Sleep. 1990 Jun;13(3):245-52.
• Schmidt-Nowara WW, Coultas DB, Wiggins C, Skipper BE, Samet JM. Snoring in a Hispanic-American population. Risk factors and association with hypertension and other morbidity. Arch Intern Med. 1990 Mar;150(3):597-601.

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

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