NCT05452018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

July 13, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2022

Completed
Last Updated

February 16, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

June 29, 2022

Last Update Submit

February 15, 2023

Conditions

Healthy Volunteers

Keywords

SwallowingElectromyogramIntramuscular sensorsMuscular activity

Outcome Measures

Primary Outcomes (1)

  • 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

    2 hours

Secondary Outcomes (3)

  • Measurement of the TM time variable

    2 hours

  • Measurement of the TS time variable

    2 hours

  • Measurement of the TD time variable

    2 hours

Other Outcomes (3)

  • Measurement of amplitude of signals for each type of swallowing and non-swallowing tasks

    2 hours

  • Measurement of integral of signals for each type of swallowing and non-swallowing tasks

    2 hours

  • Measurement of Root Mean Square of signals for each type of swallowing and non-swallowing tasks

    2 hours

Study Arms (1)

First intervention group

EXPERIMENTAL

Recordings of muscle activity during swallowing

Other: Intervention group

Interventions

Intervention groupOTHER

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

First intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index (BMI) \< 25
  • Affiliated with the social security plan or beneficiary of such a system
  • Having signed the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ihab Atallah

Grenoble, 38043, France

Location

Study Officials

  • Ihab Atallah, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single group assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 11, 2022

Study Start

July 13, 2022

Primary Completion

November 11, 2022

Study Completion

November 11, 2022

Last Updated

February 16, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)