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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Device: Orofacial Myofunctional Rehabilitation Pacifier

• Registration Number: NCT06489223
• Lead Sponsor: Hospices Civils de Lyon

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 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-07-04
• Study First Posted: 2024-07-05
• Study Start: 2024-12-11
• Primary Completion: 2025-03-26
• Study Completion: 2025-03-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of an Orofacial Myofunctional Rehabilitation Pacifier	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.

Primary Outcome Measures

Name	Time	Method
assess the acceptability of the pacifier in the mouth while awake	Day 1 inclusion	cumulative time during which the pacifier is kept in the mouth over three 15-minute sessions of awake testing. The pacifier will be judged as accepted if at least 15 minutes of pacifier in the mouth are accumulated over the 3 tests carried out.

Secondary Outcome Measures

Name	Time	Method
Evaluate whether the pacifier is held in the mouth while awake	Day 1 inclusion	Number of times the child rejects the pacifier and the maximum duration of uninterrupted hold in the mouth during the 15 minutes of each test
Evaluate how well the pacifier stays in the mouth during sleep	Day 1 inclusion, during the night	Time during which the pacifier is kept in the mouth during sleep until spontaneous rejection, measured from a video recording, correlated to the parameters recorded by polysomnography (sleep efficiency, apnea-hypopnea index, number of microphones -arousals, total sleep time and sleep latency).
Evaluate the attitude of infants when taking the pacifier in the mouth	Day 1 inclusion	presence of grimaces when offering the pacifier in the mouth or non-nutritive sucking behavior during each test
Assessment of the safety of the pacifier in infants	Day 1 inclusion	Recording of any adverse events

Trial Locations

Locations (1)

Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon; 🇫🇷 Lyon, France