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

Civil Hospices of Lyon

Status: Completed

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Device: Orofacial Myofunctional Rehabilitation Pacifier

Study type: Interventional

Funder types: Other

Identifiers

NCT06489223

69HCL23_0811

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 4 weeks to 6 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Use of an Orofacial Myofunctional Rehabilitation Pacifier

Experimental group

Description:

The device will be offered to the child during waking periods during three tests which will be programmed remotely or not from a bottle. Each of this tests will last 15 minutes. Tests taking place near a meal must take place within 20 minutes before or after the bottle. The last test will be offered at bedtime with the aim of the child falling asleep with the device.

Treatment:

Device: Orofacial Myofunctional Rehabilitation Pacifier