Prevalence of Sleep-Disordered Breathing in Children

NCT ID: NCT00022789

Last Updated: 2014-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-08-31

Study Completion Date

2006-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Lung Diseases Sleep Apnea Syndromes

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Edward Bixler

Professor, Vice Chair Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward O. Bixler, PhD

Role: STUDY_CHAIR

Milton S. Hershey Medical Center

Locations

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Pennsylvania State University Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL063772

Identifier Type: NIH

Identifier Source: secondary_id

View Link

980

Identifier Type: -

Identifier Source: org_study_id

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