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.
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
20
Grenoble University Hospital
Grenoble, France
RECRUITINGConcomitant 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
Time frame: 1 year
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
Time frame: 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.
Time frame: 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.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.