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COMPLETEDNA

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

NCT06489223•Hospices Civils de Lyon

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

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

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

Lyon, France

Key Dates

Start Date

December 11, 2024

Primary Completion Date

March 26, 2025

Completion Date

March 26, 2025

Last Updated

April 13, 2025

Enrollment

ACTUAL participants

Conditions

Obstructive Sleep Apnea Syndrome

Interventions

Orofacial Myofunctional Rehabilitation Pacifier

DEVICE

Fascial Mobilization Along the Vagus Nerve and Its Effects on Acute Physiological Parameters in Obstructive Sleep Apnea

NCT07169058

Obstructive Sleep Apnea Syndromes

View study

WITHDRAWNNA

Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children

NCT05164211

Obstructive Sleep Apnea Syndrome

View study

COMPLETEDPHASE3

Osteopathy and Obstructive Sleep Apnea Syndrome II

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

Fascial Mobilization Along the Vagus Nerve and Its Effects on Acute Physiological Parameters in Obstructive Sleep Apnea

Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children

Osteopathy and Obstructive Sleep Apnea Syndrome II

PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea

Obstructive Sleep Apnea Syndrome: Evaluation of the Efficacy of Sleepinnov© (Spiri+) Continuous Positive Airway Pressure Device

Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome.