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

Hearing Loss Clinical Trial

— MELAUDI-2  

Official title:

Evaluation of the Global Auditory Nerve Activity as a New Method of Electrophysiological Exploration of Hearing in Humans - 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552224
• Other study ID #: 9890
• Status: Completed
• Phase: N/A
• Start date: July 11, 2018
• Est. completion date: June 26, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 26, 2021
• Est. primary completion date: June 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Procedure:
• Recording of auditory nerve activity
near field recording of auditory nerve activity with contact electrode

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Institute for Neurosciences of Montpellier U1051, Reims University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude of global evoked auditory nerve activity		36 months
Primary	Spectrum of global evoked auditory nerve activity		36 months
Secondary	Mesure of peristimulus time responses of evoked auditory nerve activity		36 months