Assessment of a New Tool to Measure Tongue Muscle Function (TOM1)
The Iowa Oral Performance Instrument (IOPI) is currently the reference tool for assessing tongue muscle function, measuring the pressure exerted by the tongue on an air-filled bulb. However, several limitations reduce its precision and clinical relevance. To overcome these, the TOngue Manometer (TOM) has been developed. This crossover study compares the two devices in healthy adults, hypothesizing that the TOM's interface will enable participants to produce higher maximal tongue pressure and endurance values, closer to their ground truth.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Pierre Cnockaert, MSc
- 电话号码：+32478136109
- 邮箱：pierre.cnockaert@outlook.com
学习地点
-
-
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Brussels、比利时、1200
- 招聘中
- Institut de Recherche Expérimentale et Clinique (IREC) - UCLouvain; Lung, Nose, and Skin (LUNS) lab
-
接触：
- Pierre Cnockaert, MSc
- 邮箱：pierre.cnockaert@outlook.com
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首席研究员：
- Pierre Cnockaert, MSc
-
-
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
描述
Inclusion Criteria:
- Being a healthy adult aged 18 to 65 years old
- Being able to understand and speak French
Exclusion Criteria:
- Being diagnosed with a cardiorespiratory or neuromuscular disease
- Being diagnosed with obstructive sleep apnea-hypopnea syndrome
- Any reason preventing the participant from completing the measurement protocol (e.g., oral pain, severe cognitive impairment, lack of cooperation, illiteracy)
- Being involved in an oropharyngeal rehabilitation program
- Having dysphagia
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：TOM session
|
New, lab-made device |
|
有源比较器：IOPI session
|
The device currently identified as gold standard for tongue muscles assessment |
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 |
|---|---|---|
|
Tongue Pmax in elevation (pElev)
大体时间：Throughout the entire study, approximately during 14 months
|
Tongue maximal pressure (kPa) in elevation, either with the TOM or the IOPI, depending on the visit and the randomization order |
Throughout the entire study, approximately during 14 months
|
|
Tongue endurance in elevation (eElev)
大体时间：Throughout the entire study, approximately during 14 months
|
Endurance time (sec.), i.e., time during which the tongue can sustain 50% of its Pmax in elevation, measured either with the TOM or the IOPI, depending on the visit and the randomization order |
Throughout the entire study, approximately during 14 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body mass index (kg/m^2)
大体时间：Throughout the entire study, approximately during 14 months
|
Throughout the entire study, approximately during 14 months
|
|
|
Mouth, tongue, and face assessment test (through MBLF test)
大体时间：Throughout the entire study, approximately during 14 months
|
This test (MBLF test, for 'test de motricité bucco-linguo-faciale') features an assessment of several muscles (e.g., lips, tongue, and face area) that are assessed on a scale from 0 (no contraction / severe asymmetry) to 3 (normal contraction / complete symmetry). |
Throughout the entire study, approximately during 14 months
|
|
Mouth breathing questionnaire
大体时间：Throughout the entire study, approximately during 14 months
|
A score 0-3 suggests high likelihood of habitual nose breathing; 4-7 a suspicion of mouth breathing; 8 or higher a high likelihood of habitual mouth breathing |
Throughout the entire study, approximately during 14 months
|
|
Tongue thickness (POCUS)
大体时间：Throughout the entire study, approximately during 14 months
|
A submental and neck ultrasound will be performed to assess tongue muscles thickness (cm) |
Throughout the entire study, approximately during 14 months
|
合作者和调查者
调查人员
- 学习椅：William Poncin, PhD、Université Catholique de Louvain
研究记录日期
研究主要日期
学习开始 (实际的)
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.