Analysis of Mandibular Movements in Ventilated Children With Sleep Apnea Syndrome

Recruiting

• Conditions: Apnea Syndrome; Obstructive Sleep Apnea

• Registration Number: NCT05908188
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-12-20
• Status Verified: 2023-02
• Study Start: 2023-02-15
• Study First Submitted QC: 2023-06-08
• Last Update Submitted: 2023-06-08
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18
• Primary Completion: 2023-09-01
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	1 year	during one night in hospital and one night at home

Secondary Outcome Measures

Name	Time	Method
The Obstructive Respiratory disturbance Index (ORDI) reproductibility	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.
Residual obstructive airway events detected by mandibular movements and integrated continuous positive pressure or non invasive ventilation monitoring software.	1 year	the number of apnea and obstructive hypopnea per hour
The difference in the Obstructive Respiratory disturbance Index (ORDI) before and after the modification of ventilatory parameters	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.

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 Grenoble, France