Prevalence of Sleep-Disordered Breathing in Children
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Purpose
To investigate the prevalence and clinical significance of sleep-disordered breathing (SDB) in children.
| Condition |
|---|
|
Lung Diseases Sleep Apnea Syndromes |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Prevalence of Sleep Disordered Breathing in Children |
| Enrollment: | 700 |
| Study Start Date: | August 2001 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
BACKGROUND:
SDB in children appears to be a common condition, affecting approximately 1 to 3 percent of children. Many aspects of childhood SDB remain understudied and poorly understood, including its precise prevalence, the optimal means of identifying children who should undergo polysomnography, and the potentially major impact of this condition on health, cognitive development, and behavior.
DESIGN NARRATIVE:
The population-based, cross-sectional study of 6- to 16-year-old schoolchildren in Dauphin County, Pennsylvania is a two-part study. In the first part of the study, parents of every child enrolled in local elementary schools will complete a questionnaire that will assess general sleep, behavior, and learning problems. In the second part of the study, 1,000 children will be randomly selected based on their risk for SDB, as determined by the questionnaire. They will be evaluated in a sleep laboratory to determine the presence of SDB. A thorough pediatric ear, nose, throat, and pulmonary evaluation will be conducted; school records and behavior will also be assessed. The parents of the children will be interviewed, and information will be collected on the family history of risk factors associated with childhood SDB. This strategy will be beneficial in establishing the prevalence and clinical significance of SDB in children.
Eligibility| Ages Eligible for Study: | 5 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Random representative population sample of children in elementary school (K-5)
Inclusion Criteria:
- Phase I: Sampled all children by questionnaire completed by parent or guardian in three school districts in Dauphin County, Pennsylvania
- Phase II: Recruited a representative sample of 700 to complete a more detailed analysis in the laboratory
Contacts and Locations| United States, Pennsylvania | |
| Pennsylvania State University Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Study Chair: | Edward O. Bixler, PhD | Milton S. Hershey Medical Center |
More Information
No publications provided
| Responsible Party: | Michael S Yarnell, Director, Grants Administration, Pennsylvania State University Hershey Med Ctr |
| ClinicalTrials.gov Identifier: | NCT00022789 History of Changes |
| Other Study ID Numbers: | 980, R01 HL63772 |
| Study First Received: | August 14, 2001 |
| Last Updated: | August 13, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
|
Sleep-Disordered Breathing |
Additional relevant MeSH terms:
|
Respiratory Aspiration Lung Diseases Sleep Apnea Syndromes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Apnea Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013