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A Study to Examine the Relationship Between Sleep Apnea and Cleft Lip/Palate
This study is currently recruiting participants.
Verified by University of Rochester, September 2006
First Received: September 8, 2005   Last Updated: February 12, 2009   History of Changes
Sponsored by: University of Rochester
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00156442
  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: Prospective
Official Title: OSAS in Children With Cleft Lip/Palate

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 100
Study Start Date: September 2005
Estimated Primary Completion Date: December 2010 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156442

Contacts
Contact: Margaret-Ann Carno, PhD, RN 585-273-4743 margaret_carno@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Margaret-Ann Carno, PhD, RN     585-273-4743     margaret_carno@urmc.rochester.edu    
Principal Investigator: John Girotto, MD            
Sub-Investigator: Heidi V. Connolly, MD            
Sub-Investigator: ChinTo Fong, MD            
Sub-Investigator: Heather Adams, PhD            
Sub-Investigator: Margaret-Ann Carno, PhD,RN            
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: U of Rochester ( John Girrotto MD )
Study ID Numbers: 11595
Study First Received: September 8, 2005
Last Updated: February 12, 2009
ClinicalTrials.gov Identifier: NCT00156442     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Mouth Diseases
Sleep Apnea Syndromes
Cleft Lip
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic
Signs and Symptoms
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Stomatognathic Diseases
Congenital Abnormalities

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

ClinicalTrials.gov processed this record on September 11, 2009