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Clinical Trials/NCT01046591
NCT01046591
Completed
Not Applicable

Sleep and Neurobehavioral Performance After Cleft Palate Repair

University of Michigan1 site in 1 country82 target enrollmentDecember 2006
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ConditionsCleft Palate

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cleft Palate
Sponsor
University of Michigan
Enrollment
82
Locations
1
Primary Endpoint
Severity of obstructive sleep apnea
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
December 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Louise O'Brien

Associate Professor

University of Michigan

Eligibility Criteria

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

Outcomes

Primary Outcomes

Severity of obstructive sleep apnea

Time Frame: Within 24 hours of enrollment.

Secondary Outcomes

  • Hyperactivity scores(Within 24 hours of enrollment.)

Study Sites (1)

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