Sleep and Behavior in Children With Cleft Palate

Completed

• Conditions: Cleft Palate
• Interventions: Procedure: Polysomnography

• Registration Number: NCT01046591
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-06
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cleft	Polysomnography	Those with a repaired cleft palate
Comparison	Polysomnography	Those without a cleft palate repair

Primary Outcome Measures

Name	Time	Method
Severity of obstructive sleep apnea	Within 24 hours of enrollment.

Secondary Outcome Measures

Name	Time	Method
Hyperactivity scores	Within 24 hours of enrollment.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States