NCT05908188

Analysis of Mandibular Movements in Ventilated Children With Sleep Apnea Syndrome

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Apnea Syndrome
• Obstructive Sleep Apnea

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2023-06-18
• Last updated: 2023-06-18

Locations

1 site across 1 country: France