Sleep and Behavior in Children With Cleft Palate

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Louise O'Brien, University of Michigan
ClinicalTrials.gov Identifier:
NCT01046591
First received: January 11, 2010
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Cleft Palate
Procedure: Polysomnography

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Sleep and Neurobehavioral Performance After Cleft Palate Repair

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Severity of obstructive sleep apnea [ Time Frame: Within 24 hours of enrollment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hyperactivity scores [ Time Frame: Within 24 hours of enrollment. ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: December 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cleft
Those with a repaired cleft palate
Procedure: Polysomnography
Overnight sleep studies will be performed on all children.
Other Names:
  • PSG
  • Overnight polysomnography
Comparison
Those without a cleft palate repair
Procedure: Polysomnography
Overnight sleep studies will be performed on all children.
Other Names:
  • PSG
  • Overnight polysomnography

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children will be recruited from cleft palate clinics

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046591

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Louise M O'Brien, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Louise O'Brien, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01046591     History of Changes
Other Study ID Numbers: R000041, 1R21HL087819-01A2
Study First Received: January 11, 2010
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Michigan:
Cleft Palate
Cleft Lip
Obstructive Sleep Apnea
Sleep-Disordered Breathing
Behavior
Learning

Additional relevant MeSH terms:
Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014