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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Intervention group

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Ihab Atallah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of amplitude of signals for each type of swallowing and non-swallowing tasks	Measure of amplitude of signals for each type of swallowing tasks (of different types of food bowls) and non-swallowing tasks (turning the head, opening the mouth, talking, smiling)	2 hours
Measurement of integral of signals for each type of swallowing and non-swallowing tasks	Measure of integral of signals for each type of swallowing tasks (of different types of food bowls) and non-swallowing tasks (turning the head, opening the mouth, talking, smiling)	2 hours
Measurement of Root Mean Square of signals for each type of swallowing and non-swallowing tasks	Measure of Root Mean Square of signals for each type of swallowing tasks (of different types of food bowls) and non-swallowing tasks (turning the head, opening the mouth, talking, smiling)	2 hours

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: GIPSA-LAB; Clinical Investigation Centre for Innovative Technology Network
• Investigators: Principal Investigator: Ihab Atallah, MD, PhD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Actual): November 11, 2022
• Study Completion (Actual): November 11, 2022

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Electromyogram; Swallowing; Intramuscular sensors; Muscular activity
• Other Study ID Numbers: 38RC22.0096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No