Detection of Early Swallowing Time by Electromyogram and Sound Recording in Healthy Volunteers. Single-center, Prospective, Not-controlled, Not-randomized, Open-label Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Intramuscular electromyography measurement of the activity of muscles of interest during the performance of a set of swallowing tasks.
研究概览
简要总结
The objective of this study is to show the feasibility of detecting the specific activity of 2 muscles during swallowing using invasive sensors in healthy volunteers.
详细描述
Total laryngectomy, which involves removing the larynx and performing a tracheostomy, is the standard method of surgical treatment for advanced laryngeal cancer.
It changes the patient's life and has an significant impact on his overall quality of life.
Over the last 10 years, numerous trials of artificial larynx implantation have been tested, but currently there is no method of implanting a system that detects the onset of a swallow.
The DEGLUTITION study aims to show the feasibility of detecting the specific activity of 2 muscles in swallowing using intramuscular electromyograms in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) < 25
- •Affiliated with the social security plan or beneficiary of such a system
- •Having signed the informed consent
排除标准
- •With chewing and/or swallowing disorders, or a history of chewing and/or swallowing disorders.
- •With bleeding disorders (including patients on anticoagulants)
- •With neurological disorders
- •With a history of cervical surgery
- •With immune deficiency
- •Participating in an interventional study that may interfere with this study
- •Protected person concerned by the articles L1121-5 to L1121-8 of the Public Health Code
结局指标
主要结局
Intramuscular electromyography measurement of the activity of muscles of interest during the performance of a set of swallowing tasks.
时间窗: 2 hours
Absence or presence of visible activity on recorded signal during a swallow with the possibility to extract the TM moment (activation timing of the muscles of interest) of each muscle of interest
次要结局
- Measurement of the TM time variable(2 hours)
- Measurement of the TS time variable(2 hours)
- Measurement of the TD time variable(2 hours)