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Completed

NCT Number: NCT00456573

Cytokine Profiles in Children With Obstructive Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tonsillectomy

Procedure

medically indicated tonsillectomy in subjects with and without OAS

Primary outcomes

  1. levels of cytokines released from PBMCs of OAS subjects and controls

    Time frame: just prior to surgery

Secondary outcomes

  1. cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups

    Time frame: at time of surgery

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 5, 2007
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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