Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea

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).

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Key information

Conditions

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

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

urine leukotriene level

Time frame: baseline

assess urinary leukotriene E4 levels in children with obstructive sleep apnea (OSA

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Eastern Virginia Medical School

Other

Collaborators

Medarva

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jul 31, 2014
Registry last updated: Feb 6, 2018

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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Completed