Coding of Speech Signals in the Human Auditory Nerve (NeuroSpeech)

Coding of Speech Signals in the Human Auditory Nerve - an Exploratory Study

The fine evaluation of the function of auditory neurons in silence and in noise in humans is difficult, if not impossible, to date with the conventional methods available. That is why in certain situations, the hearing aids of patient with hearing loss fail, especially in the presence of noise.

In this study the investigators aim at investigating the global spontaneous and sound evoked human auditory nerve activity from electrophysiological acquisitions performed directly on the cochlear nerve in patients requiring posterior fossa surgery.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss
• Intervention / Treatment: Procedure: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode

Detailed Description

The fine evaluation of the function of auditory neurons in silence and in noise in humans is difficult, if not impossible, to date with the conventional methods available. That is why in certain situations, the hearing aids of patient with hearing loss fail, especially in the presence of noise.

In this study the investigators aim at investigating the global spontaneous and sound evoked human auditory nerve activity from electrophysiological acquisitions performed directly on the cochlear nerve in patients requiring posterior fossa surgery.

Stimulations will be performed in silence and in noise from stimuli identical to those used during the preoperative auditory assessment: clic and speech syllable stimulation. These acquisitions will allow us to compare clinical and electrophysiological data in order to better understand the coding of hearing in normal and hearing loss humans under silent and noisy conditions. A prospective longitudinal study will be performed.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xavier DUBERNARD; Phone Number: 0033 03.26.78.68.92; Email: xdubernard@chu-reims.fr

Study Locations

• France
  • Reims, France
    • Recruiting
    • Damien JOLLY
    • Contact: Xavier DUBERNARD; Phone Number: 0033 03.26.78.68.92; Email: xdubernard@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

inclusion criteria :

Will be included as hearing impaired patients:

• male or female
• over 18 years of age
• who are to undergo surgery on the cerebellopontine angle (microvascular decompression, vestibular neurotomy, removal of a meningioma or schwannoma tumor)
• with a mild to severe sensorineural hearing loss defined by an average hearing loss (average of thresholds obtained at 500, 1000, 2000 and 4000 Hz) greater than 20 dB and less than 90 dB in pure tone bone conduction audiometry on the side of the operated ear.
• affiliated to a social security system.
• have read the information note describing the study and have agreed in writing to participate by signing the informed consent form.

Will be included as normal hearing patients:

• male or female
• over 18 years of age
• who are to undergo surgery in the cerebellopontine angle (microvascular decompression, vestibular neurotomy, removal of a meningioma or schwannoma tumor)
• free of neuro-sensory deafness, defined by average hearing thresholds less than or equal to 20 dB in tonal bone conduction audiometry on the side of the operated ear
• affiliated with a social security system.
• having read the information note describing the study and having agreed in writing to participate by signing the informed consent form.

exclusion criteria :

Patients for whom the auditory nerve is not accessible during surgery,

• because of a complete tumor invasion of the cochlear nerve (stage III and IV neuroma, advanced meningioma)
• because of an anatomical feature not identified during the preoperative examination, making its exposure for recordings impossible (protrusion of the posterior face of the rock)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subjects with no hearing loss	Procedure: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode; During surgery using a retro-sigmoid approach in the cerebellopontine angle (microvascular decompression, vestibular neurotomy, meningioma or schwannoma removal), near-field recording of human auditory nerve activity using a contact electrode is performed on patients with normal or impaired hearing threshold. Each patient is explored preoperatively by hearing tests in noise and in silence. During the operation, stimuli are delivered in silence and in noise, under the same conditions as during the preoperative auditory exploration.
Experimental: subjects with hearing loss	Procedure: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode; During surgery using a retro-sigmoid approach in the cerebellopontine angle (microvascular decompression, vestibular neurotomy, meningioma or schwannoma removal), near-field recording of human auditory nerve activity using a contact electrode is performed on patients with normal or impaired hearing threshold. Each patient is explored preoperatively by hearing tests in noise and in silence. During the operation, stimuli are delivered in silence and in noise, under the same conditions as during the preoperative auditory exploration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the amplitude of global evoked auditory nerve activity	Compare the amplitude and spectrum of global evoked auditory nerve activity in silence and in noise with basic and speech stimuli between patients defined as normo and hearing loss based on preoperative audiometric tests.	66 months
Compare the spectrum of global evoked auditory nerve activity	Compare the spectrum of global evoked auditory nerve activity in silence and in noise with basic and speech stimuli between patients defined as normo and hearing loss based on preoperative audiometric tests	66 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the difference of coding of the temporal envelope	Compare the difference of coding of the temporal envelope of the collected signal in the normo and hearing impaired groups.	66 months
Compare the difference of coding of the fine structure	Compare the difference of coding of the fine structure of the collected signal in the normo and hearing impaired groups.	66 months
Compare the two groups of investigation	To investigate within the group of normo hearing patients whether the amplitude of global evoked auditory nerve activity is different between those with the best and worst results in the pre-operative vocal speech in noise test.	66 months
Compare the two groups of investigation	To investigate within the group of normo hearing patients whether the spectrum of global evoked auditory nerve activity is different between those with the best and worst results in the pre-operative vocal speech in noise test.	66 months

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Estimated): June 7, 2027
• Study Completion (Estimated): June 7, 2027

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Hearing Loss; Deafness; Ear Diseases; Hearing Disorders in noise and in silence
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: PO21089

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No