NCT01046591

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

5 years

First QC Date

January 11, 2010

Last Update Submit

March 6, 2012

Conditions

Cleft Palate

Keywords

Cleft PalateCleft LipObstructive Sleep ApneaSleep-Disordered BreathingBehaviorLearning

Outcome Measures

Primary Outcomes (1)

  • Severity of obstructive sleep apnea

    Within 24 hours of enrollment.

Secondary Outcomes (1)

  • Hyperactivity scores

    Within 24 hours of enrollment.

Study Arms (2)

Cleft

Those with a repaired cleft palate

Procedure: Polysomnography

Comparison

Those without a cleft palate repair

Procedure: Polysomnography

Interventions

PolysomnographyPROCEDURE

Overnight sleep studies will be performed on all children.

Also known as: PSG, Overnight polysomnography
CleftComparison

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children will be recruited from cleft palate clinics

You may qualify if:

  • Previous cleft palate repair
  • Age 6-15 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Cleft PalateCleft LipSleep Apnea, ObstructiveSleep Apnea SyndromesBehavior

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMouth AbnormalitiesMouth DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLip DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Louise M O'Brien, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 12, 2010

Study Start

December 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

US(1)