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

Healthy Volunteers Clinical Trial

— DEGLUTITION  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05452018
• Other study ID #: 38RC22.0096
• Status: Completed
• Phase: N/A
• Start date: July 13, 2022
• Est. completion date: November 11, 2022

Study information

• Verified date: January 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 11, 2022
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Intervention group
In healthy volunteers, activity measurement of muscles of interest by intramuscular electromyography during predefined swallowing tasks

Locations

Country	Name	City	State
France	Ihab Atallah	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Centre for Innovative Technology Network, GIPSA-LAB

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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