Assessment of a New Tool to Measure Tongue Muscle Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Tongue Pmax in elevation (pElev)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being a healthy adult aged 18 to 65 years old
- •Being able to understand and speak French
排除标准
- •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
研究组 & 干预措施
TOM session
干预措施: TOngue Manometer (TOM) device (Device)
IOPI session
干预措施: IOPI (Device)
结局指标
主要结局
Tongue Pmax in elevation (pElev)
时间窗: 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
Tongue endurance in elevation (eElev)
时间窗: 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
次要结局
- Body mass index (kg/m^2)(Throughout the entire study, approximately during 14 months)
- Mouth, tongue, and face assessment test (through MBLF test)(Throughout the entire study, approximately during 14 months)
- Mouth breathing questionnaire(Throughout the entire study, approximately during 14 months)
- Tongue thickness (POCUS)(Throughout the entire study, approximately during 14 months)