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OpenTrials
Completed

NCT Number: NCT01046591

Sleep and Behavior in Children With Cleft Palate

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.

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Key information

Conditions

Cleft Palate Apnea Behavior Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Dyssomnias Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Procedure

Overnight sleep studies will be performed on all children.

Other names: PSG, Overnight polysomnography

Primary outcomes

  1. Severity of obstructive sleep apnea

    Time frame: Within 24 hours of enrollment.

Secondary outcomes

  1. Hyperactivity scores

    Time frame: Within 24 hours of enrollment.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Sleep and Neurobehavioral Performance After Cleft Palate Repair

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jan 12, 2010
Registry last updated
Mar 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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