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NCT Number: NCT06490237

Coding of Speech Signals in the Human Auditory Nerve

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Compare the amplitude of global evoked auditory nerve activity

    Time frame: 66 months

    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.

  2. Compare the spectrum of global evoked auditory nerve activity

    Time frame: 66 months

    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

Secondary outcomes

  1. Compare the difference of coding of the temporal envelope

    Time frame: 66 months

    Compare the difference of coding of the temporal envelope of the collected signal in the normo and hearing impaired groups.

  2. Compare the difference of coding of the fine structure

    Time frame: 66 months

    Compare the difference of coding of the fine structure of the collected signal in the normo and hearing impaired groups.

  3. Compare the two groups of investigation

    Time frame: 66 months

    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.

  4. Compare the two groups of investigation

    Time frame: 66 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xavier DUBERNARD

CONTACT

[email protected]

03.26.78.68.92 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: NeuroSpeech

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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