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Prevalence of Sleep-Disordered Breathing in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00022789
First Posted: August 14, 2001
Last Update Posted: March 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Edward Bixler, Milton S. Hershey Medical Center
August 14, 2001
August 14, 2001
March 13, 2014
August 2001
June 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00022789 on ClinicalTrials.gov Archive Site
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Prevalence of Sleep-Disordered Breathing in Children
Prevalence of Sleep Disordered Breathing in Children
To investigate the prevalence and clinical significance of sleep-disordered breathing (SDB) in children.

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.

Observational
Observational Model: Cohort
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Probability Sample
Random representative population sample of children in elementary school (K-5)
  • Lung Diseases
  • Sleep Apnea Syndromes
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
November 2006
June 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00022789
980
R01HL063772 ( U.S. NIH Grant/Contract )
No
Not Provided
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Edward Bixler, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Edward O. Bixler, PhD Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
March 2014