Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT02205346
• Lead Sponsor: Eastern Virginia Medical School

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Primary Completion: 2016-06
• Study Completion: 2016-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-02
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
urine leukotriene level	baseline	assess urinary leukotriene E4 levels in children with obstructive sleep apnea (OSA

Secondary Outcome Measures

Name	Time	Method
correlation between Urine LTE4 and the apnea hypopnea index (AHI)	baseline	determine if there is a correlation between urine LTE4 levels and the severity score as determined by the AHI

Trial Locations

Locations (1)

Children's Hospital of the King's Daughters; 🇺🇸 Norfolk, Virginia, United States