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

NCT ID: NCT05452018

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-13

Study Completion Date

2022-11-11

Brief Summary

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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

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group assignment
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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First intervention group

Recordings of muscle activity during swallowing

Group Type EXPERIMENTAL

Intervention group

Intervention Type OTHER

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

Interventions

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Intervention group

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinical Investigation Centre for Innovative Technology Network

NETWORK

Sponsor Role collaborator

GIPSA-LAB

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ihab Atallah, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Ihab Atallah

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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38RC22.0096

Identifier Type: -

Identifier Source: org_study_id

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