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

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Completed
• CT.gov ID: NCT03552224
• Collaborator: Institute for Neurosciences of Montpellier U1051 (Other), Reims University Hospital (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 35.5
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss	Procedure: Recording of auditory nerve activity	N/A

Study Design

• Study Type: Interventional
• 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: Jul 11, 2018
• Actual Primary Completion Date: Jun 26, 2021
• Actual Study Completion Date: Jun 26, 2021

Arms and Interventions

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

Primary Outcome Measures

1. Amplitude of global evoked auditory nerve activity [36 months]

2. Spectrum of global evoked auditory nerve activity [36 months]

Secondary Outcome Measures

1. Mesure of peristimulus time responses of evoked auditory nerve activity [36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: 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:

• 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

Locations

	Site	City	State	Country	Postal Code
1	CHU Montpellier	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier
• Institute for Neurosciences of Montpellier U1051
• Reims University Hospital

Investigators

• Principal Investigator: Frédéric VENAIL, PU-PH, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT03552224
• Other Study ID Numbers: 9890
• First Posted: Jun 11, 2018
• Last Update Posted: Dec 30, 2021
• Last Verified: Dec 1, 2021

• 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: Hearing Loss; Deafness

Study Results

No Results Posted as of Dec 30, 2021