Study of Acceptability and Tolerance of an Orofacial Myofunctional Rehabilitation Pacifier in Infants

Study of Acceptability and Tolerance of an Orofacial Myofunctional Rehabilitation Pacifier in Infants

The development of the medical device tested was inspired by palatal plates used to treat myofunctional disorders in young patients with Down syndrome.

This protocol is intended to evaluate the acceptability and tolerance of this pacifier in infants aged 1 to 6 months during 4 test.

If acceptability and tolerance are satisfactory, an effectiveness study will be carried out to determine whether this medical device could prove useful in preventing the occurrence of Obstructive Sleep Apnea Syndrome (OSAS) in very young children, via orofacial myofunctional rehabilitation

Inclusion Criteria:

• Infant aged 4 weeks to 6 months coming to the pediatric sleep department to perform a polysomnography or polygraphy with video, during hospitalization of at least 24 hours,
• Affiliate or beneficiary of a social security scheme,
• With informed consent of the 2 legal representatives.

Exclusion Criteria:

• Known allergy to silicone.