NCT03817762

Brief Summary

The use of respiratory polygraphy (RP) in children for the diagnosis of obstructive sleep apnea hypopnea syndrome (OSAHS) can be challenging: device acceptance, sensors displacement. The automatic analysis of respiratory events has never been evaluated in a pediatric population. The primary objective of this study was to determine the feasibility of pediatric RP in an ENT department routine practice. The second objective was to evaluate the reliability of the automatic signal analysis in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 years 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
4 months until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
Last Updated

January 29, 2019

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

October 4, 2018

Last Update Submit

January 25, 2019

Conditions

Obstructive Sleep Apnea Hypopnea Syndrome

Keywords

pediatric obstructive sleep apnea hypopnea syndromepediatric respiratory polygraphydevice acceptancesignal qualityautomatic detection of respiratory events

Outcome Measures

Primary Outcomes (1)

  • Overall signal quality of the respiratory polygraph

    retrospective data collection : Overall signal quality of RP (Respiratory polygraphy)

    1 day

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age between 2 and 12 years
  • child having performed a ventilatory polygraph for suspicion of obstructive hypopnoea apnea syndrome

You may not qualify if:

  • \- over 12 years old

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
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2018

First Posted

January 25, 2019

Study Start

January 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2018

Last Updated

January 29, 2019

Record last verified: 2018-10

Locations

FR(1)