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Cytokine Profiles in Children With Obstructive Sleep Apnea

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
University of Chicago

Study Description
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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 Phase
Obstructive Sleep Apnea Syndrome Procedure: tonsillectomy Not Applicable

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 Design
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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

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

Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Fuad M. Baroody, MD, University ofChicago
ClinicalTrials.gov 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:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases