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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orofacial Myofunctional Rehabilitation Pacifier | Device | The pacifier will be offered to the child |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the attitude of infants when taking the pacifier in the mouth | presence of grimaces when offering the pacifier in the mouth or non-nutritive sucking behavior during each test | Day 1 inclusion |
| Evaluate whether the pacifier is held in the mouth while awake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia FRANCO | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon | Lyon | 69500 | France |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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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 |
| Day 1 inclusion |
| Evaluate how well the pacifier stays in the mouth during sleep | 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). | Day 1 inclusion, during the night |
| Assessment of the safety of the pacifier in infants | Recording of any adverse events | Day 1 inclusion |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |