Obstructive Sleep Apnea Syndrome
Conditions
Keywords
Obstructive Sleep Apnea Syndrome, pacifier
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
Interventions
DEVICEOrofacial Myofunctional Rehabilitation Pacifier
The pacifier will be offered to the child
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 6 Months
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assess the acceptability of the pacifier in the mouth while awake | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the attitude of infants when taking the pacifier in the mouth | Day 1 inclusion | presence of grimaces when offering the pacifier in the mouth or non-nutritive sucking behavior during each test |
| Evaluate whether the pacifier is held in the mouth while awake | 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 |
| Evaluate how well the pacifier stays in the mouth during sleep | 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). |
| Assessment of the safety of the pacifier in infants | Day 1 inclusion | Recording of any adverse events |
Countries
France
Outcome results
None listed