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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Healthy Volunteers

Treatments

Other: Intervention group

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT05452018
38RC22.0096

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

First intervention group
Experimental group
Description:
Recordings of muscle activity during swallowing
Treatment:
Other: Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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