NCT00022789

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

August 14, 2001

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

4.8 years

First QC Date

August 14, 2001

Last Update Submit

March 12, 2014

Conditions

Lung DiseasesSleep Apnea Syndromes

Keywords

Sleep-Disordered Breathing

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennsylvania State University Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Lung DiseasesSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Edward O. Bixler, PhD

    Milton S. Hershey Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Vice Chair Research

Study Record Dates

First Submitted

August 14, 2001

First Posted

August 14, 2001

Study Start

August 1, 2001

Primary Completion

June 1, 2006

Study Completion

November 1, 2006

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

US(1)