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Evaluation of the Global Auditory Nerve Activity for Exploration of Hearing in Humans (MELAUDI-2)

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Recording of auditory nerve activity
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hearing Loss focused on measuring Evoked auditory nerve activity, Hearing Loss, Tinnitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 - 80 years ( inclusive borders)
  • patient having to undergo surgery at the level of the ponto-cerebellar angle (microvascular decompression, vestibular neurotomy, tumor resection of the meningioma type or schwannoma) and
  • Unaffected by neuro-sensory hearing loss, defined by mean auditory thresholds of less than 20 dB in tone audiometry in bone conduction on the side of the ear to be operated (N = 15, Group 1) or
  • Showing mild to moderate hearing loss defined by average hearing loss (average of 500, 1000, 2000 and 4000 Hz thresholds) greater than 20 dB and less than 55 dB in air conduction threshold tone audiometry (N = 15 Group 2).
  • Voluntary subjects to participate in the study,
  • Subjects having signed written consent to participate in the study,
  • Easily accessible topics.

Exclusion Criteria:

  • Subjects unable to understand the nature and goals of the study and / or having difficulty communicating with the investigator,
  • Subjects refusing to participate, subjects whose free and informed consent has not been sought, subjects for which a consent form has not been signed,
  • Subjects for whom there is a contraindication to general anesthesia,
  • Subjects with a central neurological pathology that can disrupt electrophysiological recordings
  • Not affiliated to a French social security scheme or not benefiting from such a scheme,
  • Majors protected by law,
  • Pregnant women,
  • deprived of liberty by judicial or administrative decision,
  • Infectious or inflammatory pathology of the middle ear.

Sites / Locations

  • CHU Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Subjects with no hearing loss

Subjects with hearing loss

Arm Description

Subjects referred for cerebellopontine angle surgery with no hearing loss with recording of auditory nerve activity by contact electrode

Subjects referred for cerebellopontine angle surgery with hearing loss with recording of auditory nerve activity by contact electrode

Outcomes

Primary Outcome Measures

Amplitude of global evoked auditory nerve activity
Spectrum of global evoked auditory nerve activity

Secondary Outcome Measures

Mesure of peristimulus time responses of evoked auditory nerve activity

Full Information

First Posted
May 23, 2018
Last Updated
December 29, 2021
Sponsor
University Hospital, Montpellier
Collaborators
Institute for Neurosciences of Montpellier U1051, Reims University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03552224
Brief Title
Evaluation of the Global Auditory Nerve Activity for Exploration of Hearing in Humans
Acronym
MELAUDI-2
Official Title
Evaluation of the Global Auditory Nerve Activity as a New Method of Electrophysiological Exploration of Hearing in Humans - 2
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
June 26, 2021 (Actual)
Study Completion Date
June 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Institute for Neurosciences of Montpellier U1051, Reims University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To date, all the electrophysiological methods for auditory testing rely on the measure on synchronous evoked auditory nerve activity. This measure only takes into account the response of the first action potential in every auditory fibber, but provides no information about the neural response during a sustained activity. This can explain why in experimental models, a loss of more of 80% of auditory nerve fibbers cannot be detected by usual electrophysiological measurements. In this study we aim at investigating the global spontaneous and sound evoked auditory nerve activity by recording directly the electrical field by an electrode placed directly on the auditory nerve of subjects during a skull base surgical procedure. We expected to demonstrated differences in the electrical activity between subjects with or without hearing loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Evoked auditory nerve activity, Hearing Loss, Tinnitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects with no hearing loss
Arm Type
Experimental
Arm Description
Subjects referred for cerebellopontine angle surgery with no hearing loss with recording of auditory nerve activity by contact electrode
Arm Title
Subjects with hearing loss
Arm Type
Experimental
Arm Description
Subjects referred for cerebellopontine angle surgery with hearing loss with recording of auditory nerve activity by contact electrode
Intervention Type
Procedure
Intervention Name(s)
Recording of auditory nerve activity
Intervention Description
near field recording of auditory nerve activity with contact electrode
Primary Outcome Measure Information:
Title
Amplitude of global evoked auditory nerve activity
Time Frame
36 months
Title
Spectrum of global evoked auditory nerve activity
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Mesure of peristimulus time responses of evoked auditory nerve activity
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 - 80 years ( inclusive borders) patient having to undergo surgery at the level of the ponto-cerebellar angle (microvascular decompression, vestibular neurotomy, tumor resection of the meningioma type or schwannoma) and Unaffected by neuro-sensory hearing loss, defined by mean auditory thresholds of less than 20 dB in tone audiometry in bone conduction on the side of the ear to be operated (N = 15, Group 1) or Showing mild to moderate hearing loss defined by average hearing loss (average of 500, 1000, 2000 and 4000 Hz thresholds) greater than 20 dB and less than 55 dB in air conduction threshold tone audiometry (N = 15 Group 2). Voluntary subjects to participate in the study, Subjects having signed written consent to participate in the study, Easily accessible topics. Exclusion Criteria: Subjects unable to understand the nature and goals of the study and / or having difficulty communicating with the investigator, Subjects refusing to participate, subjects whose free and informed consent has not been sought, subjects for which a consent form has not been signed, Subjects for whom there is a contraindication to general anesthesia, Subjects with a central neurological pathology that can disrupt electrophysiological recordings Not affiliated to a French social security scheme or not benefiting from such a scheme, Majors protected by law, Pregnant women, deprived of liberty by judicial or administrative decision, Infectious or inflammatory pathology of the middle ear.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric VENAIL, PU-PH
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Evaluation of the Global Auditory Nerve Activity for Exploration of Hearing in Humans

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