Prevalence of Sleep-Disordered Breathing in Children

Completed

• Conditions: Lung Diseases; Sleep Apnea Syndromes

• Registration Number: NCT00022789
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

To investigate the prevalence and clinical significance of sleep-disordered breathing (SDB) in children.

Detailed Description

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.

Study Timeline

• Study Start: 2001-08
• Study First Submitted QC: 2001-08-13
• Study First Submitted: 2001-08-14
• Study First Posted: 2001-08-14
• Primary Completion: 2006-06
• Study Completion: 2006-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Pennsylvania State University Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States