Hearing LossNeuroSpeechNCT06490237
Coding of Speech Signals in the Human Auditory Nerve
A study testing near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode in people with Hearing Loss, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- 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
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2021to 7 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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)
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, 03.26.78.68.92 ext. 0033, xdubernard@chu-reims.fr
About this study
Official title: Coding of Speech Signals in the Human Auditory Nerve - an Exploratory Study
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode
- Keywords
- Hearing Loss, Deafness, Hearing Disorders in noise and in silence, Ear Diseases
- Medical subject headings
- Hearing Loss, Deafness, Ear Diseases
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, vestibular neurotomy, meningioma or schwannoma removal), 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 in noise and in silence. During the operation, stimuli are delivered in silence and in noise, under the same conditions as during the preoperative auditory exploration.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with no hearing loss | Active comparator | Not described Receives: Procedure: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode |
| subjects with hearing loss | Experimental | Not described 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.
Compare the amplitude of global evoked auditory nerve activity
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.
Measured: 66 months
Compare the spectrum of global evoked auditory nerve activity
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
Measured: 66 months
Secondary outcomes (4)
Compare the difference of coding of the temporal envelope
Compare the difference of coding of the temporal envelope of the collected signal in the normo and hearing impaired groups.
Measured: 66 months
Compare the difference of coding of the fine structure
Compare the difference of coding of the fine structure of the collected signal in the normo and hearing impaired groups.
Measured: 66 months
Compare the two groups of investigation
To investigate within the group of normo hearing patients whether the amplitude of global evoked auditory nerve activity is different between those with the best and worst results in the pre-operative vocal speech in noise test.
Measured: 66 months
Compare the two groups of investigation
To investigate within the group of normo hearing patients whether the spectrum of global evoked auditory nerve activity is different between those with the best and worst results in the pre-operative vocal speech in noise test.
Measured: 66 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start7 Dec 2021
- Primary completion7 Jun 2027 (estimated)
- Study completion7 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- 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
- 60 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
- NCT06490237
- Sponsor's protocol ID
- PO21089
- Acronym
- NeuroSpeech
- Status last verified
- Jun 2024
- First submitted
- 3 Aug 2021
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coding of Speech Signals in the Human Auditory Nerve - an Exploratory Study
- ClinicalTrials.gov ID
- NCT06490237
- Acronym / sponsor ID
- NeuroSpeech / PO21089
- Conditions
- Hearing Loss
- Keywords
- Hearing Loss, Deafness, Hearing Disorders in noise and in silence, Ear Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 7 Jun 2027 (estimated)
- Study completion
- 7 Jun 2027 (estimated)
- First posted
- 8 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.
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with no hearing loss | Active comparator | Procedure: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode |
| subjects with hearing loss | Experimental | Procedure: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
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, vestibular neurotomy, meningioma or schwannoma removal), 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 in noise and in silence. During the operation, stimuli are delivered in silence and in noise, under the same conditions as during the preoperative auditory exploration. | Procedure or surgery | Subjects with no hearing loss, subjects with hearing loss |
Primary outcome
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
4 secondary outcomes
Compare the difference of coding of the temporal envelope
Time frame: 66 months
Compare the difference of coding of the fine structure
Time frame: 66 months
Compare the two groups of investigation
Time frame: 66 months
Compare the two groups of investigation
Time frame: 66 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 8 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 Hearing Loss, 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 14 inclusion and 3 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 8 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 (03.26.78.68.92 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?
Compare the amplitude of global evoked auditory nerve activity (time frame: 66 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 8 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.