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NCT00456573 Clinical Trial

Cytokine Profiles in Children With Obstructive Sleep Apnea

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:
Local and Systemic Cytokine Profiles in Children With Obstructive Sleep Apnea and Controls

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00456573
Other study ID # 002 (14437B)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2006
Est. completion date December 1, 2008

Study information
Verified date May 2023
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 1, 2008
Est. primary completion date September 1, 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Months to 12 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• tonsillectomy
medically indicated tonsillectomy in subjects with and without OAS

Locations
Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary levels of cytokines released from PBMCs of OAS subjects and controls just prior to surgery
Secondary cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups at time of surgery
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