Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea

February 2, 2018 updated by: Eastern Virginia Medical School
Investigate urinary leukotriene E4 levels and determine if there is a correlation with severity of obstructive sleep apnea. The investigators then would like to determine a threshold level which could then be used for confirmation of diagnosis of obstructive sleep apnea (OSA).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Children's Hospital of the King's Daughters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Otolaryngology practice

Description

Inclusion Criteria:

  • children 2-16 years of age
  • scheduled for polysomnogram

Exclusion Criteria:

  • cardiovascular, neuromuscular, immunologic or craniofacial disorders
  • pharmacologic treatment including corticosteroids and leukotriene receptor antagonists in the last month
  • subjects who have already received treatment for OSA with an oral appliance, continuous positive airway pressure (CPAP) device
  • previously undergone tonsillectomy and/or adenoidectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urine leukotriene level
Time Frame: baseline
assess urinary leukotriene E4 levels in children with obstructive sleep apnea (OSA
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between Urine LTE4 and the apnea hypopnea index (AHI)
Time Frame: baseline
determine if there is a correlation between urine LTE4 levels and the severity score as determined by the AHI
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Virginia Medical School

Collaborators

Medarva

Investigators

  • Principal Investigator: Cristina Baldassari, MD, EVMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

July 31, 2014

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • October 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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