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

NCT06489223 | Completed

• 1 other identifier: 69HCL23_0811
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Obstructive Sleep Apnea Syndrome; pacifier

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluate the attitude of infants when taking the pacifier in the mouth

  Day 1 inclusion

• Evaluate whether the pacifier is held in the mouth while awake

  Day 1 inclusion

• Evaluate how well the pacifier stays in the mouth during sleep

  Day 1 inclusion, during the night

• Assessment of the safety of the pacifier in infants

  Day 1 inclusion

Study Arms (1)

Use of an Orofacial Myofunctional Rehabilitation Pacifier

EXPERIMENTAL

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

Interventions

Orofacial Myofunctional Rehabilitation Pacifier DEVICE

The pacifier will be offered to the child

Use of an Orofacial Myofunctional Rehabilitation Pacifier

Eligibility Criteria

• Age: 4 Weeks - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Known allergy to silicone.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Lyon, 69500, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Patricia FRANCO

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: December 11, 2024
• Primary Completion: March 26, 2025
• Study Completion: March 26, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)