NCT06489223

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 4 Weeks – 6 Months
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Orofacial Myofunctional Rehabilitation Pacifier	The pacifier will be offered to the child

Timeline

• Start date: 2024-12-11
• Primary completion: 2025-03-26
• Completion: 2025-03-26
• First posted: 2024-07-05
• Last updated: 2025-04-13

Locations

1 site across 1 country: France