Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with advancement using a mandibular advancement appliance (MGA™)
研究概览
简要总结
Assessment of the association of maxillary expansion using a rapid palatal expansion, use of a mandibular advancement appliance (MGA™) and of a device allowing sleep in a semi-seated position (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™ constitute the Yookid system™.
详细描述
Obstructive Sleep Apnea syndrome (OSA) shows a 10% morbidity rate in children with a higher rate between the ages of 3 and 5. Generally speaking, its prevalence is underestimated. Furthermore, detecting OSA remains difficult due to its particular physiopathology. The decrease in nasopharyngeal airway dimensions is the most common etiology. This decrease is related to soft tissues as well as maxillomandibular abnormalities. The aim of the study is to show that reducing sleep apnea in children remains possible when inducing rapid palatal expansion and mandibular advancement using the Yookid™ system. The Yookid™ system associates a mandibular advancement appliance and repositioning of the patient during sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5 to 7 year-old children
- •Children with American Society of Anesthesiologists score (ASA) of 1 and 2
- •Children with signs of OSA during examination and clinical exam
- •Children with apnea-hypopnea index (AHI) from 1 to 5 (one to five sleep apnea / hour during PSG)
- •Children with a class II division 1 angle malocclusion (at the canines level rotation center) and skeletal class II according to Delaire analysis
排除标准
- •OSA associated to syndromic disorder and/or syndrome
- •Body/Mass Index (BMI) > 97ème percentile according to development curves (obese children)
- •Central sleep apnea
- •Respiratory allergy
- •Previous ear, nose and throat (ENT) surgery
- •Hypertrophic tonsils needing surgery
- •Adenoid hypertrophy needing surgery
- •Patients with ankyloglossia
结局指标
主要结局
Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with advancement using a mandibular advancement appliance (MGA™)
时间窗: Day 180
Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with a device allowing a semi-seated sleeping position (YooBreath™)
时间窗: Day 180
次要结局
- Assessment of quality of wakefulness(Day 180)
- Sleep improvement(Day -7, day 180)
- Assessment of quality of sleep(Day 180)
- Measurement of lengthening of mandibular body and ramus(Day -7, day 180)
- Assessment of intensity of dental pain the morning on waking after using the MGA™ system(Day 60, day 90, day 120, day 150, day 180)
- Assessment of salivary disorders the morning on waking after using the MGA™ system(Day 60, day 90, day 120, day 150, day 180)
- Improvement of breathing(Day -7, day 180)
- Assessment of dental occlusion(Day -7, day 180)
- Assessement by the child and the parents of the treatment and the devices used(Day 180)
- Assessment of the compliance(Day 0, day 15, day 60, day 90, day 120, day 150, day 180)
- Assessment of intensity of pain during rapid palatal expansion(Day 60)
- Assessment of duration of pain during rapid palatal expansion(Day 60)
- Assessment of duration of dental pain the morning on waking after using the MGA™ system(Day 60, day 90, day 120, day 150, day 180)
- Assessment of risk of falling using the Yoobreath system™(Day 15, day 60, day 90, day 120, day 150, day 180)
- Assessment of pain related to the semi-seated position(Day 15, day 60, day 90, day 120, day 150, day 180)
- Assessment of disorders in falling asleep and sleep quality (micro arousals)(Day 15, day 60, day 90, day 120, day 150, day 180)