Sleep and Behavior in Children With Cleft Palate

Cleft Palate Clinical Trial

Official title:

Sleep and Neurobehavioral Performance After Cleft Palate Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046591
• Other study ID #: R000041
• Secondary ID: 1R21HL087819-01A
• Status: Completed
• Phase: N/A
• First received: January 11, 2010
• Last updated: March 6, 2012
• Start date: December 2006
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cleft Palate

Intervention

Procedure:
• Polysomnography
Overnight sleep studies will be performed on all children.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of obstructive sleep apnea		Within 24 hours of enrollment.	No
Secondary	Hyperactivity scores		Within 24 hours of enrollment.	No