Cytokine Profiles in Children With Obstructive Sleep Apnea

NCT ID: NCT00456573

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-01

Study Completion Date

2008-12-01

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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tonsillectomy

medically indicated tonsillectomy in subjects with and without OAS

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fuad M Baroody, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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002 (14437B)

Identifier Type: -

Identifier Source: org_study_id

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