Sleep and Behavior in Children With Cleft Palate

March 6, 2012 updated by: Louise O'Brien, University of Michigan

Sleep and Neurobehavioral Performance After Cleft Palate Repair

The purpose of this study is to determine whether cleft palate repair increases the risk for obstructive sleep apnea in children and whether sleep apnea could explain learning and behavior difficulties that are often observed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children will be recruited from cleft palate clinics

Description

Inclusion Criteria:

  • Previous cleft palate repair
  • Age 6-15 years

Exclusion Criteria:

  • Other condition that impacts the interpretation of PSG or neurobehavioral assessments
  • Being treated for sleep apnea with CPAP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cleft
Those with a repaired cleft palate
Procedure: Polysomnography
Overnight sleep studies will be performed on all children.
Other Names:
  • PSG
  • Overnight polysomnography
Comparison
Those without a cleft palate repair
Procedure: Polysomnography
Overnight sleep studies will be performed on all children.
Other Names:
  • PSG
  • Overnight polysomnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severity of obstructive sleep apnea
Time Frame: Within 24 hours of enrollment.
Within 24 hours of enrollment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Hyperactivity scores
Time Frame: Within 24 hours of enrollment.
Within 24 hours of enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Louise M O'Brien, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 6, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R000041
  • 1R21HL087819-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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