Urinary Leukotriene E4 Levels in Children With Obstructiv... | NCT02205346

Studies
Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea

NCT02205346

Sponsor

Eastern Virginia Medical School

Status

Completed

Last Update Posted

Feb 6, 2018Actual

Enrollment

130Actual

Phase

Not provided

Conditions

Obstructive Sleep Apnea

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Jun 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jul 29, 2014

First Submission Date that Met QC Criteria

Jul 30, 2014

First Posted Date

Jul 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2018

Last Update Posted Date

Feb 6, 2018Actual

Name	Class
Medarva	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

130Actual

Label	Type	Description	Intervention Names
no treatment		no treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Otolaryngology practice

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cristina Baldassari, MD	EVMS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of the King's Daughters		Norfolk	Virginia	23507	United States

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided