Prevalence of Sleep-Disordered Breathing in Children

Lung Diseases Clinical Trial

Official title:

Prevalence of Sleep Disordered Breathing in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022789
• Other study ID #: 980
• Secondary ID: R01HL063772
• Status: Completed
• Phase: N/A
• First received: August 14, 2001
• Last updated: March 12, 2014
• Start date: August 2001
• Est. completion date: November 2006

Study information

• Verified date: March 2014
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: November 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Lung Diseases
• Sleep Apnea Syndromes

Locations

Country	Name	City	State
United States	Pennsylvania State University Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States,