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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Intervention group

• Registration Number: NCT05452018
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-11
• Study Start: 2022-07-13
• Primary Completion: 2022-11-11
• Study Completion: 2022-11-11
• Status Verified: 2023-01
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
First intervention group	Intervention group	Recordings of muscle activity during swallowing

Primary Outcome Measures

Name	Time	Method
Intramuscular electromyography measurement of the activity of muscles of interest during the performance of a set of swallowing tasks.	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

Secondary Outcome Measures

Name	Time	Method
Measurement of the TM time variable	2 hours	The TM time variable is assessed in milliseconds by intramuscular electromyography measurement and corresponding to activation timing of the muscles of interest
Measurement of the TS time variable	2 hours	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.
Measurement of the TD time variable	2 hours	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.

Trial Locations

Locations (1)

Ihab Atallah; 🇫🇷 Grenoble, France