Structure CochleaCosySpeechNCT06499584
Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocalizations
A study testing near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode in people with Structure Cochlea and Temporal Envelope Cochlea, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Structure Cochlea, Temporal Envelope Cochlea
- What is being tested?
- near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Xavier DUBERNARD, 03 26 78 71 25, xdubernard@chu-reims.fr
Marc LABROUSSE, 03 26 78 71 25, mlabrousse@chu-reims.fr
About this study
Official title: The Functional Role of Cochlear Synaptopathy for Speech Coding in the Brain
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.
Read the 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.
- Conditions
- Structure Cochlea, Temporal Envelope Cochlea
- Being tested
- near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode
- Keywords
- Hearing Loss, Deafness, Micro vascular decompression, Otoneurosurgery, Retrosigmoid approach
- Medical subject headings
- Hearing Loss, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near field recording of human auditory nerve activity during retro sigmoid approach with contact electrodeProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 48 months
Secondary outcomes (4)
The spectrum of the temporal envelope of the signal
To 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.
Measured: At 48 months
The amplitude of the temporal envelope of the
To 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.
Measured: at 48 months
The spectrum of the fine structure of the signal
To 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.
Measured: at 48 months
The amplitude of the fine structure of the signal
To 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.
Measured: at 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start21 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Structure CochleaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499584
- Sponsor's protocol ID
- PO23102
- Acronym
- CosySpeech
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Functional Role of Cochlear Synaptopathy for Speech Coding in the Brain
- ClinicalTrials.gov ID
- NCT06499584
- Acronym / sponsor ID
- CosySpeech / PO23102
- Conditions
- Structure Cochlea, Temporal Envelope Cochlea
- Keywords
- Hearing Loss, Deafness, Micro vascular decompression, Otoneurosurgery, Retrosigmoid approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal hearing patients | Experimental | Procedure: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrodefree 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. |
| hearing impaired patients | Experimental | Procedure: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrodewith sensorineural hearing loss defined by average hearing thresholds between 21 dB HL and 40 dB HL at 0.5, 1, 2 and 4 kHz. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- The following will be included as hearing-impaired patients:
- Will be included as normal-hearing patients:
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| near field recording of human auditory nerve activity during retro sigmoid approach with contact electrodeDuring 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. | Procedure or surgery | hearing impaired patients, normal hearing patients |
Primary outcome
To compare the amplitude of coding of complex and ecological sounds
Time frame: 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
Time frame: 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.
4 secondary outcomes
The spectrum of the temporal envelope of the signal
Time frame: At 48 months
The amplitude of the temporal envelope of the
Time frame: at 48 months
The spectrum of the fine structure of the signal
Time frame: at 48 months
The amplitude of the fine structure of the signal
Time frame: at 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode in people with Structure Cochlea and Temporal Envelope Cochlea, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier DUBERNARD (03 26 78 71 25 ext. 0033, xdubernard@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the amplitude of coding of complex and ecological sounds (time frame: At 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.