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

NCT06489223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-04-13

No results posted yet for this study

Summary

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

Conditions

  • Obstructive Sleep Apnea Syndrome

Interventions

DEVICE

Orofacial Myofunctional Rehabilitation Pacifier

The pacifier will be offered to the child

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Patricia FRANCO · Hospices Civils de Lyon

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Weeks
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-11
Primary Completion
2025-03-26
Completion
2025-03-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06489223 on ClinicalTrials.gov