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Cytokine Profiles in Children With Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00456573
Recruitment Status : Unknown
Verified June 2008 by University of Chicago.
Recruitment status was:  Recruiting
First Posted : April 5, 2007
Last Update Posted : June 3, 2008
Information provided by:
University of Chicago

Brief Summary:
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 or disease Intervention/treatment
Obstructive Sleep Apnea Syndrome Procedure: tonsillectomy

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Local and Systemic Cytokine Profiles in Children With Obstructive Sleep Apnea and Controls
Study Start Date : April 2006
Estimated Primary Completion Date : September 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Procedure: tonsillectomy
    medically indicated tonsillectomy in subjects with and without OAS

Primary Outcome Measures :
  1. levels of cytokines released from PBMCs of OAS subjects and controls [ Time Frame: just prior to surgery ]

Secondary Outcome Measures :
  1. cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups [ Time Frame: at time of surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00456573

Contact: Fuad M Baroody, MD 773-702-4790

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

Responsible Party: Fuad M. Baroody, MD, University ofChicago Identifier: NCT00456573     History of Changes
Other Study ID Numbers: 002 (14437B)
First Posted: April 5, 2007    Key Record Dates
Last Update Posted: June 3, 2008
Last Verified: June 2008

Keywords provided by University of Chicago:
Pediatric Obstructive sleep apnea syndrome

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases