A Study to Examine the Relationship Between Sleep Apnea and Cleft Lip/Palate - Full Text View

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

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

MedlinePlus related topics:

Cleft Lip and Palate Sleep Apnea

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Cross-Sectional, Defined Population, Retrospective/Prospective Study

Official Title:	OSAS in Children With Cleft Lip/Palate

Further study details as provided by University of Rochester:

Estimated Enrollment:	100
Study Start Date:	September 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	1 Year to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Study ID Numbers:	11595
First Received:	September 8, 2005
Last Updated:	September 6, 2006
ClinicalTrials.gov Identifier:	NCT00156442
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:

Pathologic Processes

Disease

Mouth Abnormalities

Syndrome

Nervous System Diseases

Stomatognathic System Abnormalities

Lip Diseases

ClinicalTrials.gov processed this record on September 05, 2008