Detection of Early Swallowing Time by Electromyogram and Sound Recording in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Detection of Early Swallowing Time by Electromyogram and Sound Recording in Healthy Volunteers. Single-center, Prospective, Not-controlled, Not-randomized, Open-label Study.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Other: Intervention group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) < 25 Affiliated with the social security plan or beneficiary of such a system Having signed the informed consent Exclusion Criteria: subjects 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single group assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First intervention group<br>Recordings of muscle activity during swallowing | Other: Intervention group<br>* In healthy volunteers, activity measurement of muscles of interest by intramuscular electromyography during predefined swallowing tasks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intramuscular electromyography measurement of the activity of muscles of interest during the performance of a set of swallowing tasks. | 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 | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the TM time variable | The TM time variable is assessed in milliseconds by intramuscular electromyography measurement and corresponding to activation timing of the muscles of interest | 2 hours | 
| Measurement of the TS time variable | Measure of TS time variable in milliseconds corresponding to passage of the food bolus through the upper esophageal sphincter. TS is assessed by signals acquired from the microphone. | 2 hours | 
| Measurement of the TD time variable | Measure of TD time variable in milliseconds corresponding to start of swallowing by activation of the submandibular area.TD is assessed by signals acquired from the microphone. | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Swallowing, Electromyogram, Intramuscular sensors, Muscular activity