Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
The tongue plays a key role in maintaining upper airway patency during sleep, mainly through the genioglossus, the principal pharyngeal dilator muscle. Its dysfunction may be linked to the development of obstructive sleep-disordered breathing (oSDB), a condition affecting more than one in ten children and associated with cardiovascular and cognitive consequences. Although adenotonsillectomy remains the treatment of choice, it fails in a substantial proportion of cases because of persistent obstruction at other sites, the tongue base being involved in one third of these cases. Therefore, a better characterization of the tongue in children with oSDB is needed, since the extent to which its structure and function contribute to upper airway obstruction in this population remains largely unknown.
Our team has established the reproducibility of tongue function measurements in healthy children and is currently building a reference database. What is still lacking is an assessment of tongue structure and function in children with oSDB. Such data would allow comparison with healthy children, thereby improving the understanding of oSDB pathophysiology and informing clinical management.
Primary objective: To describe tongue structure and function in children with oSDB.
Secondary objective: To compare tongue structure and function between children with oSDB and healthy children, using data from a previous study conducted in healthy children (TMAC study, UCLouvain).
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：William Poncin, Professor
- 电话号码：0471 90 66 23
- 邮箱：william.poncin@uclouvain.be
学习地点
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Liège、比利时、4000
- 招聘中
- CHC MontLégia hospital
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接触：
- Matthieu Thimmesch, MD
- 电话号码：0032 4 355 50 20
- 邮箱：Matthieu.THIMMESCH@chc.be
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Children with obstructive sleep-disordered breathing, with a scheduled polysomnography or who received a polysomnography within the past 6 months, and without any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III
描述
Inclusion Criteria:
- Aged 4 to 17 years
- Scheduled polysomnography, or polysomnography performed within the past 6 months
- Positive Pediatric Sleep Questionnaire (8 "yes" answers or more)
Exclusion Criteria:
- Any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III
- Any condition that could interfere with the assessments
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_CONTROL
- 时间观点：CROSS_SECTIONAL
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Unique arm, cross-sectional assessment
Single assessment visit |
This cross-sectional assessment includes outcomes related to tongue structure, tongue function, and questionnaires |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Tongue strength assessment
大体时间：At enrollment, during the single study visit (Day 1)
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Maximal pressure exerted by the tongue against an air-filled bulb (in kPa) in protrusion, elevation, and during swallowing. |
At enrollment, during the single study visit (Day 1)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Tongue morphology assessment
大体时间：At enrollment, during the single study visit (Day 1)
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Submental ultrasound in frontal and sagittal plane, to assess the thickness of tongue muscles (cm) |
At enrollment, during the single study visit (Day 1)
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Tongue frenulum assessment
大体时间：At enrollment, during the single study visit (Day 1)
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Tongue range of motion ratio, reflecting the restriction imposed by the lingual frenulum. It is computed as the maximal mouth opening with the tongue tip held at the incisive papilla (mm) divided by the maximal mouth opening (mm). |
At enrollment, during the single study visit (Day 1)
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Tongue mobility score
大体时间：At enrollment, during the single study visit (Day 1)
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Motricité Bucco-Linguo-Faciale (MBLF) test, where several movements are scored between 0 and 3 regarding muscular contraction or symmetry. |
At enrollment, during the single study visit (Day 1)
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Obstructive apnea-hypopnea index
大体时间：At enrollment, during the single study visit (Day 1)
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Number of obstructive apneas and hypopneas per hour of sleep (events/hour) assessed through polysomnography |
At enrollment, during the single study visit (Day 1)
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Breathing pattern questionnaire
大体时间：At enrollment, during the single study visit (Day 1)
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Mouth breathing questionnaire from Abreu et al., considered positive if two major items, or one major and two minor items, are answered "yes" |
At enrollment, during the single study visit (Day 1)
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Quality of life questionnaire
大体时间：At enrollment, during the single study visit (Day 1)
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PedsQL questionnaire (Pediatric Quality of Life Inventory), divided into parent report and child self-report questionnaires, with several items scored from 0 to 4. Higher scores indicate more problems related to the quality of life. |
At enrollment, during the single study visit (Day 1)
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Sleep quality questionnaire
大体时间：At enrollment, during the single study visit (Day 1)
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The Pediatric Sleep Questionnaire will be administered to parents. Items are answered "yes", "no", or "I don't know", and higher scores indicate more signs of obstructive sleep-disordered breathing. |
At enrollment, during the single study visit (Day 1)
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Sleep-related quality of life questionnaire
大体时间：At enrollment, during the single study visit (Day 1)
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The Obstructive Sleep Apnea-18 (OSA-18) questionnaire will be administered to parents. Higher scores indicate a greater impact of sleep-disordered breathing on quality of life. |
At enrollment, during the single study visit (Day 1)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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