Healthy Volunteers
Conditions
Keywords
Swallowing, Electromyogram, Intramuscular sensors, Muscular activity
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.
Interventions
OTHERIntervention group
In healthy volunteers, activity measurement of muscles of interest by intramuscular electromyography during predefined swallowing tasks
Sponsors
Clinical Investigation Centre for Innovative Technology Network
GIPSA-LAB
University Hospital, Grenoble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single group assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measurement of integral of signals for each type of swallowing and non-swallowing tasks | 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) |
| Measurement of Root Mean Square of signals for each type of swallowing and non-swallowing tasks | 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) |
| Measurement of amplitude of signals for each type of swallowing and non-swallowing tasks | 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) |
Countries
France
Outcome results
None listed