Status:
COMPLETED
Study of Acceptability and Tolerance of an Orofacial Myofunctional Rehabilitation Pacifier in Infants
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Obstructive Sleep Apnea Syndrome
Eligibility:
All Genders
4-6 years
Phase:
NA
Brief 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 accep...
Eligibility Criteria
Inclusion
- 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
- Known allergy to silicone.
Key Trial Info
Start Date :
December 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06489223
Start Date
December 11 2024
End Date
March 26 2025
Last Update
April 13 2025
Active Locations (1)
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1
Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon
Lyon, France, 69500