NCT02205346

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

2.3 years

First QC Date

July 29, 2014

Last Update Submit

February 2, 2018

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

  • urine leukotriene level

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

    baseline

Secondary Outcomes (1)

  • correlation between Urine LTE4 and the apnea hypopnea index (AHI)

    baseline

Study Arms (1)

no treatment

no treatment

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Otolaryngology practice

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine sample

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Cristina Baldassari, MD

    EVMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2014

First Posted

July 31, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

US(1)