Prevalence of Sleep-Disordered Breathing in Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Edward Bixler, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00022789
First received: August 14, 2001
Last updated: March 12, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

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)
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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Random representative population sample of children in elementary school (K-5)

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022789

Locations
United States, Pennsylvania
Pennsylvania State University Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Study Chair: Edward O. Bixler, PhD Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Edward Bixler, Professor, Vice Chair Research, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00022789     History of Changes
Other Study ID Numbers: 980, R01HL063772, R01 HL63772
Study First Received: August 14, 2001
Last Updated: March 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Milton S. Hershey Medical Center:
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 July 29, 2014