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

The Functional Role of Cochlear Synaptopathy for Speech Coding in the Brain

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06499584
Acronym
CosySpeech
Enrollment
20
Registered
2024-07-12
Start date
2023-03-21
Completion date
2027-12-31
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Structure Cochlea, Temporal Envelope Cochlea

Keywords

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

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.

Detailed description

During functional cerebellopontine angle surgery, a spherical electrode is placed on the human cochlear nerve to monitor hearing. Once the electrode is in place, clicks and speech signals with and without noise are delivered to analyze the cochlear electrophysiological signal produced. Depending on the characteristics recorded, this signal can be used to determine how fine structure and temporal envelope are encoded by the cochlea. Prior to surgery, each patient is evaluated by an audiologist to determine quiet and noise thresholds, tone and speech, electrocochleography, distortion testing, tympanometry, ABR and psychoacoustic testing.

Interventions

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.

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
To compare the amplitude of coding of complex and ecological soundsAt 48 monthsThe 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 soundsAt 48 monthsThe 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.

Secondary

MeasureTime frameDescription
The spectrum of the temporal envelope of the signalAt 48 monthsTo study the spectrum of the temporal envelope of the signal collected for each logatome in the general population studied and within the normal-hearing and hard-of-hearing groups.
The amplitude of the temporal envelope of theat 48 monthsTo study the amplitude of the temporal envelope of the signal collected for each logatome in the general population studied and within the normal-hearing and hard-of-hearing groups.
The spectrum of the fine structure of the signalat 48 monthsTo study the spectrum of the fine structure of the signal collected for each logatome in the general population studied and within the normal-hearing and hard-of-hearing groups.
The amplitude of the fine structure of the signalat 48 monthsTo study the amplitude of the fine structure of the signal collected for each logatome in the general population studied and within the normal-hearing and hard-of-hearing groups.

Countries

France

Contacts

Primary ContactXavier DUBERNARD
xdubernard@chu-reims.fr03 26 78 71 25
Backup ContactMarc LABROUSSE
mlabrousse@chu-reims.fr03 26 78 71 25

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026