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

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00156442
First received: September 8, 2005
Last updated: January 11, 2010
Last verified: September 2006
  Purpose

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.


Condition
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

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

children with celft palate and symptoms of OSA

Criteria

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
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: NCT00156442

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

No publications provided

Responsible Party: John Girrotto MD, U of Rochester
ClinicalTrials.gov Identifier: NCT00156442     History of Changes
Other Study ID Numbers: 11595
Study First Received: September 8, 2005
Last Updated: January 11, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Apnea
Cleft Lip
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014