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

N/ACompletedNCT05452018

University Hospital, Grenoble20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Intervention groupOTHER

In healthy volunteers, activity measurement of muscles of interest by intramuscular electromyography during predefined swallowing tasks

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ihab Atallah

Grenoble, France

Outcomes

Primary Outcomes

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

Time frame: 2 hours

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 2 hours

Data from ClinicalTrials.gov

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