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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
The pacifier will be offered to the child
Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon
Lyon, France
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.
Time frame: Day 1 inclusion
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
Time frame: Day 1 inclusion
Evaluate whether the pacifier is held in the mouth while awake
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
Time frame: 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).
Time frame: Day 1 inclusion, during the night
Assessment of the safety of the pacifier in infants
Recording of any adverse events
Time frame: Day 1 inclusion
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