Cytokine Profiles in Children With Obstructive Sleep Apnea - Full Text View

Sponsored by:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00456573

Purpose

The purpose of this study is to compare the cytokine profile of tonsillar and peripheral blood mononuclear cells in patients with obstructive sleep apnea (OSA) and to compare the blood mononuclear cell cytokine secretion profile between patients with obstructive sleep apnea and controls without apnea.

Condition	Intervention
Obstructive Sleep Apnea Syndrome	Procedure: tonsillectomy

Study Type:	Interventional
Study Design:	Open Label, Parallel Assignment
Official Title:	Local and Systemic Cytokine Profiles in Children With Obstructive Sleep Apnea and Controls

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea Tonsils and Adenoids

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

levels of cytokines released from PBMCs of OAS subjects and controls [ Time Frame: just prior to surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups [ Time Frame: at time of surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Intervention Details:

medically indicated tonsillectomy in subjects with and without OAS

Detailed Description:

We will recruit subjects with OSA about to undergo adenotonsillectomy and collect a blood sample and portion of their tonsils after the induction of general anesthesia. The mononuclear cells will be isolated from both these tissues and stimulated with different markers and cytokines assayed and compared. We will also recruit patients with no symptoms of OSA undergoing unrelated elective surgery and ascertain the absence of OSA by having the parents fill out a sleep questionnaire. We will then collect blood samples from these patients after the induction of anesthesia and examine the cytokine secretion profile and compare it to that of the children with OSA.

Eligibility

Ages Eligible for Study:	18 Months to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

OSA documented by polysomnography and clinical symptoms.
Patients with no symptoms of OSA and negative sleep questionnaire.

Exclusion Criteria:

Significant systemic disease except mild asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456573

Contacts

Contact: Fuad M Baroody, MD

773-702-4790

fbaroody@surgery.bsd.uchicago.edu

Locations

United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Fuad M Baaroody, MD

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:

Fuad M Baroody, MD

University of Chicago

More Information

No publications provided

Responsible Party:	University ofChicago ( Fuad M. Baroody, MD )
Study ID Numbers:	002 (14437B)
Study First Received:	April 3, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00456573 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

Pediatric Obstructive sleep apnea syndrome

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Disease
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Nervous System Diseases
Dyssomnias

Sleep Disorders
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Respiratory Tract Diseases
Syndrome
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on September 02, 2009