Study of Acceptability and Tolerance of an Orofacial Myofunctional Rehabilitation Pacifier in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- assess the acceptability of the pacifier in the mouth while awake
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Weeks 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Known allergy to silicone.
结局指标
主要结局
assess the acceptability of the pacifier in the mouth while awake
时间窗: 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.
次要结局
- Evaluate whether the pacifier is held in the mouth while awake(Day 1 inclusion)
- Evaluate how well the pacifier stays in the mouth during sleep(Day 1 inclusion, during the night)
- Evaluate the attitude of infants when taking the pacifier in the mouth(Day 1 inclusion)
- Assessment of the safety of the pacifier in infants(Day 1 inclusion)