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Cytokine Profiles in Children With Obstructive Sleep Apnea

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by University of Chicago.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00456573
First received: April 3, 2007
Last updated: June 2, 2008
Last verified: June 2008
History of Changes
  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: Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Local and Systemic Cytokine Profiles in Children With Obstructive Sleep Apnea and Controls

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:
  • cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups [ Time Frame: at time of surgery ]
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:
    Procedure: tonsillectomy
    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   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Fuad M. Baroody, MD, University ofChicago
ClinicalTrials.gov Identifier: NCT00456573     History of Changes
Other Study ID Numbers: 002 (14437B)
Study First Received: April 3, 2007
Last Updated: June 2, 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

ClinicalTrials.gov processed this record on May 25, 2017