Clinical trial NCT05908188: Analysis of Mandibular Movements in Ventilated Children With Sleep Apnea Syndrome
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Apnea Syndrome
Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
apnea syndrome
children
continuous positive pressure
non invasive ventilation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: Residual obstructive airway events detected by mandibular movements and integrated continuous positive pressure or non invasive ventilation monitoring software.
timeFrame: 1 year
measure: The Obstructive Respiratory disturbance Index (ORDI) reproductibility
timeFrame: 1 year
measure: The difference in the Obstructive Respiratory disturbance Index (ORDI) before and after the modification of ventilatory parameters
timeFrame: 1 year
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
affiliation: Grenoble Alpes University Hospital
name: Guillaume Mortamet, MD
role: PRINCIPAL_INVESTIGATOR
References:
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