Tongue Muscular Assessment in Children Referred for Polysomnography in a Context of Suspected Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- Tongue peak pressure during protrusion
研究概览
简要总结
Obstructive sleep apnea (OSA) is part of the sleep-disordered breathing spectrum. Its prevalence in children is 1-5%, and it can have negative consequences at the cardiovascular, cognitive as well as behavioral levels. In children, the first-line treatment is adenotonsillectomy. However, residual obstructive events can persist as the success rate of surgery reaches only 49% in non-obese children. Residual OSA may be explained by multiple sites of obstruction, found in 20-85% children concerned by persistent OSA. Indeed, the tongue appears among one possible primary sites of obstruction. Given the tongue's crucial role in upper-airway patency during sleep, its assessment can inform us about the myofunctional deficits involved in sleep-disordered breathing.
The primary objective of the present study is to assess tongue motor functions in children with sleep-disordered breathing and to compare them to those of healthy children (data collected in a current study (TMAC) conducted at UCLouvain, Belgium; NCT06166680), in order to document possible myofunctional deficits in children with OSA. The hypothesis is that tongue motor functions will be lower in children with sleep-disordered breathing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With suspected sleep-disordered breathing
- •Referred for polysomnography
- •Affiliated to a social security scheme
- •With informed consent from both legal representatives
排除标准
- •Insufficient comprehension of French language
- •Regarding patients with suspected OSA type I or II:
- •Neurological, cardiac, or unstable respiratory conditions other than sleep disorders and their repercussions
- •Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition)
- •Malformation of the skull, the upper airway or the oral cavity
- •Regarding patients with suspected OSA type III:
- •Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition)
- •Intellectual deficit impeding the understanding of instructions
研究组 & 干预措施
Children referred for polysomnography for suspected OSA
Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA
干预措施: Tongue Strength Assessment (Other)
Children referred for polysomnography for suspected OSA
Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA
干预措施: Polysomnography (Diagnostic Test)
Children referred for polysomnography for suspected OSA
Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA
干预措施: Subjective Assessment of Sleep-Disordered Breathing (Other)
Children referred for polysomnography for suspected OSA
Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA
干预措施: Subjective Assessment of Daytime Functioning (Other)
Children referred for polysomnography for suspected OSA
Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA
干预措施: Anthropometry (Other)
Children referred for polysomnography for suspected OSA
Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA
干预措施: Clinical Examination (Other)
Children referred for polysomnography for suspected OSA
Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA
干预措施: Orofacial Praxis Assessment (Other)
结局指标
主要结局
Tongue peak pressure during protrusion
时间窗: Day 1
Tongue peak pressure during protrusion will be measured using the IOPI (Iowa Oral Performance Instrument) device. Higher tongue pressure is considered a better outcome.
次要结局
- Respiratory effort index(Day 1)
- Respiratory effort-related arousal index (RERA)(Day 1)
- Tongue mobility restriction(Day 1)
- Tongue peak pressure during elevation and swallowing(Day 1)
- Orofacial praxis(Day 1)
- Central apnea-hypopnea index(Day 1)
- Mean CO2(Day 1)
- Max CO2(Day 1)
- Sleep onset latency(Day 1)
- Wake after sleep onset(Day 1)
- Obstructive apnea-hypopnea index (OAHI)(Day 1)
- Mixed apnea-hypopnea index(Day 1)
- Time spent with CO2 > 50mmHg(Day 1)
- Mean SpO2(Day 1)
- Desaturation index ≥ 3%(Day 1)
- Desaturation index ≥ 4%(Day 1)
- Time spent with SaO2 < 90%(Day 1)
- Total sleep time(Day 1)
- Duration of sleep N1(Day 1)
- Duration of sleep N2(Day 1)
- Duration of sleep N3(Day 1)
- Duration of REM sleep(Day 1)
- Sleep efficiency(Day 1)
- Score on Abreu's Questionnaire(Day 1)
- Score on the OSA-18 Questionnaire(Day 1)
- Score on the Pediatric Sleep Questionnaire(Day 1)
- Score on the Spruyt & Gozal Questionnaire(Day 1)
- Score on the Sleep Disturbance Scale for Children(Day 1)
- Score on the French Version of the Sleepiness Scale for Adolescents(Day 1)
- Score on the Conners Rating Scale(Day 1)
- Medical history(Day 1)