CompletedNot Applicable

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

France15 participantsStarted 2024-12-11

Plain-language 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

Who can participate

Age range4 Weeks – 6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

assess the acceptability of the pacifier in the mouth while awake

Timeframe: Day 1 inclusion

Trial details

NCT IDNCT06489223

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-26

View on ClinicalTrials.gov More Obstructive Sleep Apnea Syndrome trials