NCT03845062

Brief Summary

The role of drug-induced sleep endoscopy (DISE) in the management of obstructive sleep apnea hypopnea syndrome (OSAHS) is not precisely defined for children. The primary objective of this study was to describe the consequences of DISE in the therapeutic management for children with OSAHS. The secondary objectives were to analyze the correlation between the number of obstructive sites found during DISE, the value of apnea-hypopnea index (AHI), and the type of OSAHS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
Last Updated

February 19, 2019

Status Verified

September 1, 2018

Enrollment Period

2.7 years

First QC Date

October 4, 2018

Last Update Submit

February 18, 2019

Conditions

Obstructive Sleep Apnea Hypopnea Syndrome

Keywords

drug-induced sleep endoscopypediatric obstructive sleep apnea hypopnea syndrometongue baseepiglottisoccult laryngomalacialingual tonsillectomyepiglottopexyaryepiglottic folds division

Outcome Measures

Primary Outcomes (1)

  • sleep endoscopy

    describe the modification of therapeutic management induced by sleep endoscopy

    1 day

Secondary Outcomes (3)

  • Number of obstructive site during

    1 day

  • value of apnea-hypopnea index

    1 day

  • type obstructive hypopnoea apnea syndrome of sleep

    1 day

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with clinical obstructive sleep apnea hypopnea syndrome in University Health Center

You may qualify if:

  • \- OSAHS confirmed by overnight sleep monitoring (respiratory polygraphy or overnight polysomnography)

You may not qualify if:

  • \- Lack of data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

  • Mohamed Akkari, MD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 4, 2018

First Posted

February 19, 2019

Study Start

October 1, 2015

Primary Completion

June 1, 2018

Study Completion

August 1, 2018

Last Updated

February 19, 2019

Record last verified: 2018-09

Locations

FR(1)