Healthy VolunteersDEGLUTITIONNCT05452018
Detection of Early Swallowing Time by Electromyogram and Sound Recording in Healthy Volunteers
A study testing Intervention group in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Intervention group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2022to 11 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) < 25
- Affiliated with the social security plan or beneficiary of such a system
- Having signed the informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Intervention group
- Keywords
- Swallowing, Electromyogram, Intramuscular sensors, Muscular activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
In healthy volunteers, activity measurement of muscles of interest by intramuscular electromyography during predefined swallowing tasks
| Study group | Role | What they receive |
|---|---|---|
| First intervention group | Experimental | Recordings of muscle activity during swallowing Receives: Other: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intramuscular electromyography measurement of the activity of muscles of interest during the performance of a set of swallowing tasks.
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
Measured: 2 hours
Secondary outcomes (3)
Measurement of the TM time variable
The TM time variable is assessed in milliseconds by intramuscular electromyography measurement and corresponding to activation timing of the muscles of interest
Measured: 2 hours
Measurement of the TS time variable
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.
Measured: 2 hours
Measurement of the TD time variable
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start13 Jul 2022
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, GIPSA-LAB
- Responsible party
- Sponsor
- Investigators
- Ihab Atallah, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452018
- Sponsor's protocol ID
- 38RC22.0096
- Acronym
- DEGLUTITION
- Status last verified
- Jan 2023
- First submitted
- 29 Jun 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05452018
- Acronym / sponsor ID
- DEGLUTITION / 38RC22.0096
- Conditions
- Healthy Volunteers
- Keywords
- Swallowing, Electromyogram, Intramuscular sensors, Muscular activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, GIPSA-LAB
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| First intervention group | Experimental | Other: Intervention groupRecordings of muscle activity during swallowing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) < 25
- Affiliated with the social security plan or beneficiary of such a system
- Having signed the informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupIn healthy volunteers, activity measurement of muscles of interest by intramuscular electromyography during predefined swallowing tasks | Other | First intervention group |
Primary outcome
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
3 secondary outcomes
Measurement of the TM time variable
Time frame: 2 hours
Measurement of the TS time variable
Time frame: 2 hours
Measurement of the TD time variable
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ihab Atallah, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intramuscular electromyography measurement of the activity of muscles of interest during the performance of a set of swallowing tasks. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.