Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events

January 25, 2019 updated by: University Hospital, Montpellier

Respiratory Polygraphy in Children : Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Retrospective single center study of 50 children (32 boys and 18 girls, mean age 5.5 ± 2.3 years) who benefited from an overnight RP in an ENT hospitalization department between January and August 2016 for OSAS suspicion. Manual detection of respiratory events was performed by the same ENT specialist, and compared to the automatic analysis.

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion criteria:

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

Exclusion criteria:

- over 12 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall signal quality of the respiratory polygraph
Time Frame: 1 day
retrospective data collection : Overall signal quality of RP (Respiratory polygraphy)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

January 24, 2019

First Posted (ACTUAL)

January 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL17_0450

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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