Clinical trial NCT05452018: Detection of Early Swallowing Time by Electromyogram and Sound Recording in Healthy Volunteers
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Swallowing
Electromyogram
Intramuscular sensors
Muscular activity
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
name: GIPSA-LAB
First posted: 2022-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intramuscular electromyography measurement of the activity of muscles of interest during the performance of a set of swallowing tasks.
timeFrame: 2 hours
Secondary outcomes:
measure: Measurement of the TM time variable
timeFrame: 2 hours
measure: Measurement of the TS time variable
timeFrame: 2 hours
measure: Measurement of the TD time variable
timeFrame: 2 hours
Other outcomes:
measure: Measurement of amplitude of signals for each type of swallowing and non-swallowing tasks
timeFrame: 2 hours
measure: Measurement of integral of signals for each type of swallowing and non-swallowing tasks
timeFrame: 2 hours
measure: Measurement of Root Mean Square of signals for each type of swallowing and non-swallowing tasks
timeFrame: 2 hours
Locations:
city: Grenoble
country: France
facility: Ihab Atallah
Study officials:
affiliation: University Hospital, Grenoble
name: Ihab Atallah, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: