Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02205346

Enrollment

130

Registered

2014-07-31

Start date

2014-02-28

Completion date

2016-12-31

Last updated

2018-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results