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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
Recruitment status was: Recruiting
Sponsor:
University of Chicago
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00456573
First received: April 3, 2007
Last updated: June 2, 2008
Last verified: June 2008
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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:
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:
Detailed Description:
-
Procedure: tonsillectomy
medically indicated tonsillectomy in subjects with and without OAS
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00456573
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 July 21, 2017