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NCT02205346 Clinical Trial

Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:
Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02205346
Other study ID # October 2013
Secondary ID
Status Completed
Phase N/A
First received July 29, 2014
Last updated February 2, 2018
Start date February 2014
Est. completion date December 2016

Study information
Verified date February 2018
Source Eastern Virginia Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date December 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 2 Years to 16 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital of the King's Daughters Norfolk Virginia

Sponsors (2)
Lead Sponsor Collaborator
Eastern Virginia Medical School Medarva

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary urine leukotriene level assess urinary leukotriene E4 levels in children with obstructive sleep apnea (OSA baseline
Secondary correlation between Urine LTE4 and the apnea hypopnea index (AHI) determine if there is a correlation between urine LTE4 levels and the severity score as determined by the AHI baseline
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