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A Study to Examine the Relationship Between Sleep Apnea and Cleft Lip/Palate

This study has been completed.
Information provided by:
University of Rochester Identifier:
First received: September 8, 2005
Last updated: January 11, 2010
Last verified: September 2006

The study is to examine the relationship between sleep apnea and neurocognitive behaviors in children with cleft lip/palate. Describe the incidence and severity of obstructive sleep apnea in an unselected population of grade school aged children with surgically repaired cleft palate.

A. Is the incidence of OSA higher in children with cleft palate than age matched historical control groups? B. Are nighttime symptoms an adequate screening tool to exclude the diagnosis of OSA in children with surgically repaired cleft palate? Describe the velopharyngeal closure patterns during speech in an unselected population of grade school aged children with surgically repaired cleft palate. Describe the neurobehavioral phenotype of an unselected population of grade school aged children with surgically repaired cleft palate.

Obstructive Sleep Apnea Syndrome
Cleft Lip/Palate

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: OSAS in Children With Cleft Lip/Palate

Resource links provided by NLM:

Further study details as provided by University of Rochester:

Estimated Enrollment: 100
Study Start Date: September 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children with celft palate and symptoms of OSA

Inclusion Criteria:

  • 100 children with cleft lip/palate and signs and symptoms of OSAS, parents who can read and write English

Exclusion Criteria:

  • Parents who cannot read and write English, children with severe neurological compromise
  Contacts and Locations
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Please refer to this study by its identifier: NCT00156442

United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Principal Investigator: John Girotto, MD University of Rochester
Principal Investigator: Heidi V. Connolly, MD University of Rochester
  More Information

Responsible Party: John Girrotto MD, U of Rochester Identifier: NCT00156442     History of Changes
Other Study ID Numbers: 11595
Study First Received: September 8, 2005
Last Updated: January 11, 2010

Keywords provided by University of Rochester:
Obstructive Sleep Apnea Syndrome
Cleft lip/palate

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Cleft Lip
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities processed this record on May 24, 2017