Coding of Speech Signals in the Human Auditory Nerve
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode.
- Who it may be relevant to
- Registry conditions: Hearing Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Coding of Speech Signals in the Human Auditory Nerve - an Exploratory Study
Overview
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
- 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 t
Primary outcome measures
- Compare the amplitude of global evoked auditory nerve activity [Time frame: 66 months]
- Compare the spectrum of global evoked auditory nerve activity [Time frame: 66 months]
Secondary outcome measures (4)
- Compare the difference of coding of the temporal envelope [Time frame: 66 months]
- Compare the difference of coding of the fine structure [Time frame: 66 months]
- Compare the two groups of investigation [Time frame: 66 months]
- Compare the two groups of investigation [Time frame: 66 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Damien JOLLY — Reims
Identifiers
NCT: NCT06490237 · PO21089