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

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: Orofacial Myofunctional Rehabilitation Pacifier

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69500
    • Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: Orofacial Myofunctional Rehabilitation Pacifier; The pacifier will be offered to the child

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess the acceptability of the pacifier in the mouth while awake	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.	Day 1 inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the attitude of infants when taking the pacifier in the mouth	presence of grimaces when offering the pacifier in the mouth or non-nutritive sucking behavior during each test	Day 1 inclusion
Evaluate whether the pacifier is held in the mouth while awake	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	Day 1 inclusion
Evaluate how well the pacifier stays in the mouth during sleep	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).	Day 1 inclusion, during the night
Assessment of the safety of the pacifier in infants	Recording of any adverse events	Day 1 inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Patricia FRANCO, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2024
• Primary Completion (Actual): March 26, 2025
• Study Completion (Actual): March 26, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea Syndrome; pacifier
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 69HCL23_0811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No