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Completed

NCT Number: NCT05452018

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ihab Atallah

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention group

Other

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

Primary outcomes

  1. Intramuscular electromyography measurement of the activity of muscles of interest during the performance of a set of swallowing tasks.

    Time frame: 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 outcomes

  1. Measurement of the TM time variable

    Time frame: 2 hours

    The TM time variable is assessed in milliseconds by intramuscular electromyography measurement and corresponding to activation timing of the muscles of interest

  2. Measurement of the TS time variable

    Time frame: 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.

  3. Measurement of the TD time variable

    Time frame: 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.

Other outcomes

  1. Measurement of amplitude of signals for each type of swallowing and non-swallowing tasks

    Time frame: 2 hours

    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. Measurement of integral of signals for each type of swallowing and non-swallowing tasks

    Time frame: 2 hours

    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)

  3. Measurement of Root Mean Square of signals for each type of swallowing and non-swallowing tasks

    Time frame: 2 hours

    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)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Clinical Investigation Centre for Innovative Technology Network
  • GIPSA-LAB

Registry information

Official study title

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

Acronym: DEGLUTITION

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2022
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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