Cytokine Profiles in Children With Obstructive Sleep Apnea - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 3, 2007

Last Updated Date

June 2, 2008

Start Date ^†

April 2006

Current Primary Outcome Measures ^†

levels of cytokines released from PBMCs of OAS subjects and controls [ Time Frame: just prior to surgery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00456573 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups [ Time Frame: at time of surgery ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Other, Open Label, Parallel Assignment

Condition ^†

Obstructive Sleep Apnea Syndrome

Intervention ^†

Procedure: tonsillectomy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

December 2008

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

18 Months to 12 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Fuad M Baroody, MD

773-702-4790

fbaroody@surgery.bsd.uchicago.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00456573

Responsible Party

Fuad M. Baroody, MD, University ofChicago

Secondary IDs ^††

Study Sponsor ^†

University of Chicago

Collaborators ^††

Investigators ^†

Principal Investigator:

Fuad M Baroody, MD

University of Chicago

Information Provided By

University of Chicago

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.