Sleep and Behavior in Children With Cleft Palate

University of Michigan

Status: Completed

Conditions: Cleft Palate

Treatments: Procedure: Polysomnography

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01046591

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

R000041

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

82 participants in 2 patient groups

Cleft

Description:

Those with a repaired cleft palate

Treatment:

Procedure: Polysomnography

Comparison

Description:

Those without a cleft palate repair

Treatment:

Procedure: Polysomnography