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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-11

Study Completion Date

2025-03-26

Brief Summary

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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

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Detailed Description

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Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Use of an Orofacial Myofunctional Rehabilitation Pacifier

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.

Group Type EXPERIMENTAL

Orofacial Myofunctional Rehabilitation Pacifier

Intervention Type DEVICE

The pacifier will be offered to the child

Interventions

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Orofacial Myofunctional Rehabilitation Pacifier

The pacifier will be offered to the child

Intervention Type DEVICE

Eligibility Criteria

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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.