Analysis of Mandibular Movements in Ventilated Children With Sleep Apnea Syndrome (AMANDA)

Grenoble Alpes University Hospital Center (CHU)

Status: Enrolling

Conditions: Obstructive Sleep Apnea; Apnea Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT05908188

2021-A02697-34

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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.