Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocalizations

NCT06499584 · tracked via the Priya Life Science France tracker

Sponsor

CHU de Reims

Phase

Not applicable

Started

2023-03-21

Last updated

2024-07-12

Condition(s) studied

Structure CochleaTemporal Envelope Cochlea

Investigational drug(s) / intervention(s)

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

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), 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. During the surgery, stimuli are delivered.

Study summary

In humans, surface electrophysiological recordings of the cochlear nerve in response to a sound stimulus provide information about the cochlear's ability to encode sound. Depending on the stimulus, the fine structure and temporal envelope of the signal will vary, allowing us to determine its characteristics. By phenotyping patients before surgery using subjective and objective audiometric tests, it will be possible to isolate for each patient the moment when the fine structure disappears and when the temporal envelope is effective.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion criteria: * The following will be included as hearing-impaired patients: * Male or female * Over 18 and up to 80 years of age * Normal otoscopic examination * Scheduled for surgery on the cerebellopontine angle (microvascular decompression) * With sensorineural hearing loss defined by average hearing thresholds between 21 dB HL and 40 dB HL at 0.5, 1, 2 and 4 kHz * Affiliated to a social security scheme * Having read the information note describing the study and having agreed in writing to participate by signing the informed consent form * Will be included as normal-hearing patients: * Male or female * Over 18 and up to 80 years of age * Normal otoscopic examination * Scheduled for surgery on the cerebellopontine angle (microvascular decompression) * Free of sensorineural hearing loss, defined by average hearing thresholds of less than or equal to 20 dB HL in tonal air conduction audiometry, bilaterally on the side of the ear undergoing surgery and on the side not undergoing surgery, at 0.5, 1, 2 and 4 kHz * Affiliated to a social security scheme * Having read the information note describing the study and having agreed in writing to participate by signing the informed consent form Exclusion criteria: patients will be excluded from the study if the auditory nerve is not accessible during surgery: * Notably because of complete tumor invasion of the cochlear nerve (stage III and IV neuroma, advanced meningioma) ; * Or because of a particular anatomical feature not identified during the preoperative examination, making its exposure for recordings impossible (protrusion of the posterior face of the rock).

Primary outcome measure(s)

To compare the amplitude of coding of complex and ecological sounds — At 48 months
The goal is to compare the amplitude of coding of complex and ecological sounds (logatomes in the form of vowels or syllables: association of a consonant and a vowel) in the human auditory nerve between patients defined as normo and poorly hearing according to preoperative audiometric tests.
To compare the spectrum of coding of complex and ecological sounds — At 48 months
The goal is to compare the spectrum of coding of complex and ecological sounds (logatomes in the form of vowels or syllables: association of a consonant and a vowel) in the human auditory nerve between patients defined as normo and poorly hearing according to preoperative audiometric tests.

Trial sites (1)

Facility	City	Region	Status
Damien JOLLY	Reims	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06499584 on ClinicalTrials.gov ↗ ← All trials in France