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Clinical Trials/NCT06490237
NCT06490237RecruitingNot Applicable

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

CHU de Reims1 site in 1 country60 target enrollmentStarted: December 7, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Compare the amplitude of global evoked auditory nerve activity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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)

Arms & Interventions

Subjects with no hearing loss

Active Comparator

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

subjects with hearing loss

Experimental

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

Outcomes

Primary Outcomes

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.

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

  • Compare the two groups of investigation(66 months)
  • Compare the difference of coding of the fine structure(66 months)
  • Compare the difference of coding of the temporal envelope(66 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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