Analysis of Mandibular Movements in Ventilated Children With Sleep Apnea Syndrome (AMANDA)

June 8, 2023 updated by: University Hospital, Grenoble

Analysis of Mandibular Movements to Optimize Ventilatory Management of Children With Obstructive Sleep Apnea Syndrome Treated With Continuous Positive Airway Pressure or Non-Invasive Ventilation.

Obstructive Sleep Apnea is a common medical condition in children. Diagnosis is based on polysomnography . We conducted an open prospective non randomised clinical trial to assess the efficacy of a new medical device called SUNRISE.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Obstructive Sleep apnea affects 4 percent of children. The standard device for the diagnosis and follow up is the polysomnography (PSG). However acess for this technique is difficult and expensive in certain institutions . Moreover, not all centers are qualified to receive the pediatric population. Thus expert consensus is present on the need for the development of a less expensive and easily accessible device to ensure the equality in medical care.

Recently an innovative medical device utilising the artificial intelligence technology is used to diagnose OSA in adults by recording the mandibular movement. Martinot et al were the first to use this device in children and noted a correlation between the mandibular movements and polysomnography measurements.

A multidisciplinary approach is used in the treatment of OSA. Indeed, the treatment is based on continous positive pressure and non invasive ventilation. To better evaluate the treatment, the sensor can be an alternative allowing to analyze the mandibular movements without moving at home.

We conducted an open prospective non randomised clinical trial to assess the efficacy of a new medical device called "SUNRISE" in the diagnosis and monitoring of OSA.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

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

Study Contact

Name: Guillaume Mortamet, MD
Phone Number: +33 4 76 76 55 03
Email: gmortamet@chu-grenoble.fr

Study Contact Backup

Name: Guillaume Aubertin, MD
Phone Number: +33 1 88 32 00 00
Email: guillaume.aubertin@aphp.fr

Study Locations

France
- - Grenoble, France
    - Recruiting
    - Grenoble University Hospital
    - Contact:
      
      Guillaume Mortamet, PhD

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

Child
Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

My population consists of children aged between 5 and 18 years old with obstructive sleep apnea syndrome and treated with positive pressure ventilation and non invasive ventilation.

Description

Inclusion Criteria:

Children aged 5-18 years inclusive.
With a diagnosis of severe OSA diagnosed at PSG, defined by an apnoea-hypopnoea index ≥ 10/ hours or an apnoea index ≥ 5/ hours, and associated or not with alveolar hypoventilation.
Ventilated with noninvaisve ventilation or continuous positive airway pressure during sleep.
With a nasal or nostril interface.
Followed in one of the 2 participating centres: the Grenoble-Alpes University Hospital or the Trousseau Hospital in Paris.

Exclusion Criteria:

Patients with centrally-induced sleep apnoea syndrome.
Patients at the end of life or for whom limitation of active therapies has been established.
Patients ventilated with a naso-oral interface.

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
Concomitant detection of residual obstructive breathing events by mandibular movements recorded by the sensor in comparison with a complete polysomnography recording performed in hospital under continuous positive pressure or non invasive ventilation Time Frame: 1 year	during one night in hospital and one night at home	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual obstructive airway events detected by mandibular movements and integrated continuous positive pressure or non invasive ventilation monitoring software. Time Frame: 1 year	the number of apnea and obstructive hypopnea per hour	1 year
The Obstructive Respiratory disturbance Index (ORDI) reproductibility Time Frame: 1 year	To compare the Obstructive Respiratory disturbance Index (ORDI) (defined as the number of obstructive apneas, hypopneas, and flow limitation events per hour) calculated during the hospital recording and that calculated during the home recording.	1 year
The difference in the Obstructive Respiratory disturbance Index (ORDI) before and after the modification of ventilatory parameters Time Frame: 1 year	The difference between the ORDI ((defined as the number of obstructive apneas, hypopneas, and flow limitation events per hour) at hospital recording and at home recording.	1 year

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

Principal Investigator: Guillaume Mortamet, MD, GRENOBLE ALPES UNIVERSITY HOSPITAL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 15, 2023

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

June 8, 2023

First Posted (Estimated)

June 16, 2023

Study Record Updates

Last Update Posted (Estimated)