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Coding of Speech Signals in the Human Auditory Nerve

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06490237
Acronym
NeuroSpeech
Enrollment
60
Registered
2024-07-08
Start date
2021-12-07
Completion date
2027-06-07
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

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

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.

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.

Interventions

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.

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Compare the amplitude of global evoked auditory nerve activity66 monthsCompare 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.
Compare the spectrum of global evoked auditory nerve activity66 monthsCompare 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

Secondary

MeasureTime frameDescription
Compare the difference of coding of the temporal envelope66 monthsCompare the difference of coding of the temporal envelope of the collected signal in the normo and hearing impaired groups.
Compare the difference of coding of the fine structure66 monthsCompare the difference of coding of the fine structure of the collected signal in the normo and hearing impaired groups.
Compare the two groups of investigation66 monthsTo 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.

Countries

France

Contacts

Primary ContactXavier DUBERNARD
xdubernard@chu-reims.fr03.26.78.68.92

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026