Back to resultsCytokine Profiles in Children With Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tonsillectomy
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea Syndrome focused on measuring Pediatric Obstructive sleep apnea syndrome
Eligibility 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
Sites / Locations
- University of Chicago
Outcomes
Primary Outcome Measures
levels of cytokines released from PBMCs of OAS subjects and controls
Secondary Outcome Measures
cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00456573
Brief Title
Cytokine Profiles in Children With Obstructive Sleep Apnea
Official Title
Local and Systemic Cytokine Profiles in Children With Obstructive Sleep Apnea and Controls
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2006 (Actual)
Primary Completion Date
September 1, 2008 (Actual)
Study Completion Date
December 1, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Pediatric Obstructive sleep apnea syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
tonsillectomy
Intervention Description
medically indicated tonsillectomy in subjects with and without OAS
Primary Outcome Measure Information:
Title
levels of cytokines released from PBMCs of OAS subjects and controls
Time Frame
just prior to surgery
Secondary Outcome Measure Information:
Title
cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups
Time Frame
at time of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuad M Baroody, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cytokine Profiles in Children With Obstructive Sleep Apnea
We'll reach out to this number within 24 hrs