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Completed

NCT Number: NCT06489223

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

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

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Key information

Conditions

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

Age range

4 week–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lyon, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orofacial Myofunctional Rehabilitation Pacifier

Device

The pacifier will be offered to the child

Primary outcomes

  1. assess the acceptability of the pacifier in the mouth while awake

    Time frame: 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 outcomes

  1. Evaluate the attitude of infants when taking the pacifier in the mouth

    Time frame: Day 1 inclusion

    presence of grimaces when offering the pacifier in the mouth or non-nutritive sucking behavior during each test

  2. Evaluate whether the pacifier is held in the mouth while awake

    Time frame: 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

  3. Evaluate how well the pacifier stays in the mouth during sleep

    Time frame: 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).

  4. Assessment of the safety of the pacifier in infants

    Time frame: Day 1 inclusion

    Recording of any adverse events

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: YooTET

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2024
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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