NCT00456573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

2.4 years

First QC Date

April 3, 2007

Last Update Submit

May 3, 2023

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Pediatric Obstructive sleep apnea syndrome

Outcome Measures

Primary Outcomes (1)

  • levels of cytokines released from PBMCs of OAS subjects and controls

    just prior to surgery

Secondary Outcomes (1)

  • cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups

    at time of surgery

Interventions

tonsillectomyPROCEDURE

medically indicated tonsillectomy in subjects with and without OAS

Eligibility Criteria

Age18 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • OSA documented by polysomnography and clinical symptoms.
  • Patients with no symptoms of OSA and negative sleep questionnaire.

You may not qualify if:

  • Significant systemic disease except mild asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Fuad M Baroody, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 5, 2007

Study Start

April 1, 2006

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

US(1)