Sleep and Behavior in Children With Cleft Palate

Sleep and Neurobehavioral Performance After Cleft Palate Repair

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01046591

Enrollment

Registered

2010-01-12

Start date

2006-12-31

Completion date

2011-12-31

Last updated

2012-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Palate

Keywords

Cleft Palate, Cleft Lip, Obstructive Sleep Apnea, Sleep-Disordered Breathing, Behavior, Learning

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.

Interventions

PROCEDUREPolysomnography

Overnight sleep studies will be performed on all children.

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

6 Years to 15 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Severity of obstructive sleep apnea	Within 24 hours of enrollment.

Secondary

Measure	Time frame
Hyperactivity scores	Within 24 hours of enrollment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026