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CompletedNCT03552224MELAUDI-2Updated Dec 30, 2021

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

An interventional study of Recording of auditory nerve activity in Hearing Loss, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-30.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hearing Loss

Keywords

  • Evoked auditory nerve activity
  • Hearing Loss
  • Tinnitus
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Subjects with no hearing loss

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

    Procedure: Recording of auditory nerve activity

  • Experimental
    Subjects with hearing loss

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

    Procedure: Recording of auditory nerve activity

Interventions

  • ProcedureRecording of auditory nerve activity

    near field recording of auditory nerve activity with contact electrode

06

What researchers measure

Primary outcomes

  1. Amplitude of global evoked auditory nerve activity

    Time frame: 36 months

  2. Spectrum of global evoked auditory nerve activity

    Time frame: 36 months

Secondary outcomes

  1. Mesure of peristimulus time responses of evoked auditory nerve activity

    Time frame: 36 months

07

Study locations

1 site
  • CHU Montpellier
    Montpellier, 34295, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03552224
Lead sponsor
University Hospital, Montpellier
Collaborators
Institute for Neurosciences of Montpellier U1051, Reims University hospital
Responsible party
Sponsor
First posted
Jun 11, 2018
Start date
Jul 11, 2018
Primary completion
Jun 26, 2021
Completion
Jun 26, 2021
Last update
Dec 30, 2021

Study contacts

Frédéric VENAIL, PU-PH
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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