Coding of Speech Signals in the Human Auditory Nerve

NCT06490237 | Recruiting

• 1 other identifier: PO21089
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss

Keywords

Hearing Loss; Deafness; Hearing Disorders in noise and in silence; Ear Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Compare the difference of coding of the temporal envelope

  66 months

• Compare the difference of coding of the fine structure

  66 months

• Compare the two groups of investigation

  66 months

• Compare the two groups of investigation

  66 months

Study Arms (2)

Subjects with no hearing loss

ACTIVE COMPARATOR

Procedure: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode

subjects with hearing loss

EXPERIMENTAL

Procedure: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode

Interventions

near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode PROCEDURE

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.

Subjects with no hearing loss; subjects with hearing loss

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss; Deafness; Ear Diseases

Condition Hierarchy (Ancestors)

Hearing Disorders; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xavier DUBERNARD

CONTACT

03.26.78.68.92; xdubernard@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: July 8, 2024
• Study Start: December 7, 2021
• Primary Completion (Estimated): June 7, 2027
• Study Completion (Estimated): June 7, 2027
• Last Updated: July 8, 2024

Record last verified: 2024-06

Locations

FR (1)