Analysis of Mandibular Movements in Ventilated Children With Sleep Apnea Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Apnea Syndrome, Obstructive Sleep Apnea

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 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. | the number of apnea and obstructive hypopnea per hour | 1 year | 
| The Obstructive Respiratory disturbance Index (ORDI) reproductibility | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, apnea syndrome, children, continuous positive pressure, non invasive ventilation