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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552224
Recruitment Status : Completed
First Posted : June 11, 2018
Last Update Posted : December 30, 2021
Sponsor:
Collaborators:
Institute for Neurosciences of Montpellier U1051
Reims University Hospital
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hearing Loss Procedure: Recording of auditory nerve activity Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of the Global Auditory Nerve Activity as a New Method of Electrophysiological Exploration of Hearing in Humans - 2
Actual Study Start Date : July 11, 2018
Actual Primary Completion Date : June 26, 2021
Actual Study Completion Date : June 26, 2021

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Arms and Interventions
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Arm Intervention/treatment
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
near field recording of auditory nerve activity with contact electrode
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
near field recording of auditory nerve activity with contact electrode


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Mesure of peristimulus time responses of evoked auditory nerve activity [ Time Frame: 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552224


Locations
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France
CHU Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Institute for Neurosciences of Montpellier U1051
Reims University Hospital
Investigators
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Principal Investigator: Frédéric VENAIL, PU-PH University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03552224    
Other Study ID Numbers: 9890
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: December 30, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Evoked auditory nerve activity
Hearing Loss
Tinnitus
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases