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

NCT06499584 | Recruiting

• 1 other identifier: PO23102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Structure Cochlea; Temporal Envelope Cochlea

Keywords

Hearing Loss; Deafness; Micro vascular decompression; Otoneurosurgery; Retrosigmoid approach

Outcome Measures

Primary Outcomes (2)

• To compare the amplitude of coding of complex and ecological sounds

  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.

  At 48 months

• To compare the spectrum of coding of complex and ecological sounds

  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.

  At 48 months

Secondary Outcomes (4)

• The spectrum of the temporal envelope of the signal

  At 48 months

• The amplitude of the temporal envelope of the

  at 48 months

• The spectrum of the fine structure of the signal

  at 48 months

• The amplitude of the fine structure of the signal

  at 48 months

Study Arms (2)

normal hearing patients

EXPERIMENTAL

free of sensorineural hearing loss, defined by mean hearing thresholds of less than or equal to 20 dB HL in air conduction pure tone audiometry, bilaterally on the side of the operated ear and on the non-operated side at 0.5, 1, 2 and 4 kHz.

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

hearing impaired patients

EXPERIMENTAL

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.

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

Interventions

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), 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.

hearing impaired patients; normal hearing patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss; Deafness

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xavier DUBERNARD

CONTACT

03 26 78 71 25; xdubernard@chu-reims.fr

Marc LABROUSSE

CONTACT

03 26 78 71 25; mlabrousse@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: July 12, 2024
• Study Start: March 21, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 12, 2024

Record last verified: 2024-06

Locations

FR (1)