Hearing Loss, SensorineuralEarDiTechNCT06114680
Evaluation of the CochSyn Test Prototype to Measure Cochlear Synaptopathy
A study testing CochSyn test prototype and Universal Smart Box (USB) in people with Hearing Loss, Sensorineural and Cochlear Synaptopathy, run by University Ghent at 1 site in Belgium.
Trial summary
This study investigates a newly developed test, The CochSyn test that can quantify cochlear synaptopathy (CS) (a new type of sensorineural hearing loss (SNHL)) earlier than the current golden standard pure-tone audiogram.This newly developed test is based on auditory evoked brain potentials. Read more about this study
- Who is it for?
- Ages 18 to 87 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural, Cochlear Synaptopathy, Cochlear Hearing Loss
- What is being tested?
- CochSyn test prototype and Universal Smart Box (USB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Nov 2023to 23 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 87 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Session 1
- Test group
- 18 - 87 years old
- Flemish/Dutch as native language
- Ability to fill out a questionnaire and to perform a speech intelligibility test
- Self-reported hearing difficulties according to HHIE-s questionnaire (score of >4)
Show all 17Show fewer
- Normal audiogram (for age group 18-77): audiometric thresholds up to 4 kHz ≤ 20 dB HL and for 6 kHz ≤ 40 dB HL in at least 1 ear OR impaired audiogram (for age group 18-87): audiometric thresholds between 20.1 and 64.9 dB HL pure tone average at 0.5, 1, 2, and 4 kHz in at least 1 ear (=Mild to moderately severe hearing loss according to the recommendation by the Global Burden of Disease Expert Group on Hearing Loss)
- Control group
- 18 - 77 years old
- Flemish/Dutch as native language
- Ability to fill out a questionnaire and to perform a speech intelligibility test
- No self-reported hearing difficulties according to HHIE-s questionnaire (score of ≤4)
- Normal audiogram: audiometric thresholds up to 4 kHz ≤ 20 dB HL and for 6 kHz ≤ 40 dB HL in at least 1 ear
- Session 2
- Participation in session 1 in the test group
- 18 - 77 years old
- EFR magnitude at 4 kHz with Snap electrode in session 1 reduced by 30-100% compared to average EFR magnitude of age group 18-27 of control group (session 1)
Who cannot join
- Applicable for both sessions:
- Pregnant woman
- Breastfeeding woman
- Applicable for both sessions and the ear which fulfils the inclusion criteria:
- Chronic (longer than 6 months) permanent tinnitus
- Hearing loss due to a genetic condition, a middle ear condition, or surgery
- Congenital hearing loss
- Blocked ear canal
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates a newly developed test, The CochSyn test that can quantify cochlear synaptopathy (CS) (a new type of sensorineural hearing loss (SNHL)) earlier than the current golden standard pure-tone audiogram.This newly developed test is based on auditory evoked brain potentials. A hardware prototype (the Cochsyn test prototype) was developed to use the Cochsyn test in clinical practice. Additionally a CS-based sound-processing algorithm (CoNNear) that is designed to improve speech intelligibility in subjects that are identified to have CS, will be investigated in this study.
Read the detailed description
Cochlear synaptopathy is a new type of sensorineural hearing loss (SNHL) and is related to ageing, noise exposure and ototoxicity. There is currently no diagnostic test of CS on the market, whereas CS is an important form of SNHL. CS occurs before the golden standard clinical hearing test (pure- tone audiogram in which participants raise their hand when hearing tones of different frequencies and the threshold of hearing is determined), shows any signs of hearing damage.
The investigators have developed a test, the CochSyn test that may quantify SNHL earlier than the audiogram. The newly developed test is based on auditory evoked potentials. This is a method in which an auditory stimulus is presented, and encephalogram (EEG) electrodes capture the sound-evoked brain potentials. The most popular auditory evoked potential metric to diagnose sensorineural hearing loss (SNHL) is the auditory brainstem response (ABR). The first animal research studies on CS confirmed that the ABR wave-I amplitude is a sensitive marker of CS when the inflicted hearing damage is well-controlled and specific. Even though it can be assumed that the ABR wave-I amplitude will also be sensitive to CS in humans, it may not be a differential marker for it, and hence other candidate auditory evoked potential markers for CS have been investigated in recent studies. In particular, the envelope-following-response (EFR), has also been shown to be specific to CS in animal research studies.
EFRs are recorded using the standard ABR electrode montage but use another type of stimulus. Based on model simulations and a recent study in which the investigators compared candidate EFR markers for use in human studies , the investigators have developed a new stimulus for EFRs that uses both a different type of modulator waveform and a different analysis method than was adopted earlier.
In this trial, the investigators wish to test the performance of the new method (the CochSyn test) in listeners with or without self-reported hearing difficulties using a newly developed hardware prototype (the CochSyn test prototype), dedicated for the CochSyn-test in clinical practice. The assessment also includes the testing of a CS-based sound-processing algorithm (CoNNear) that is designed to improve speech intelligibility in subjects that are identified to have CS, based on our CochSyn test.
To this end, the investigators will first assess whether our CochSyn test prototype is equally good at capturing the standard ABR waveform as a comparator device available on the market (the Intelligent Hearing Systems Universal Smart Box). The investigators will also test which stimulation characteristics and electrode configurations for the CochSyn test are best able to quantify individual differences in standard objective hearing tests (audiogram, otoacoustic emission, speech reception thresholds) and subjective hearing complaints (validated HHIE-s questionnaire).
- Being tested
- CochSyn test prototype, Universal Smart Box (USB)
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Hidden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CochSyn test prototypeDevice
The CochSyn test prototype is intended for use in the evaluation of hearing-related disorders in adults using auditory evoked potentials. The CochSyn test prototype records biopotential waveforms that can be used for hearing screening and diagnostic applications.
Universal Smart Box (USB)Device
Commercially available EEG system intended for use in the diagnosis of hearing related disorders, hearing threshold detection, and other conditions that may affect the responses to auditory, tactile, or visual stimuli. The USB Box hardware and accompanying software programs can be used with patients of all ages. It is intended for use by trained personnel in a hospital, nursery, clinic, audiologist's office, or other appropriate setting.
| Study group | Role | What they receive |
|---|---|---|
| Session 1 - test group (self-reported hearing difficulties) | Other | 143 (130 + 10% potential drop-outs) subjects with self-reported hearing difficulties according to the HHIE-s questionnaire (score of >4) Receives: Device: CochSyn test prototype; Device: Universal Smart Box (USB) |
| Session 1 - control goup (no self-reported hearing difficulties) | Other | 66 (60 + 10% potential drop-outs) subjects with no self-reported hearing difficulties according to HHIE-s questionnaire (score of ≤4) Receives: Device: CochSyn test prototype; Device: Universal Smart Box (USB) |
| Session 2 (self-reported hearing difficulties) | Other | 66 (60 + 10% potential drop-outs) subjects who participated in session 1 - test group Receives: Device: CochSyn test prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Cochsyn test prototype
The difference in terms of wave amplitudes of a standard clinical auditory brainstem response (ABR) recorded with the commercially available USB device and with the CochSyn test prototype during session 1.
Measured: end of session 1, after 3 hours
Sensitivity CochSyn test prototype
The difference in sensitivity (i.e., standard deviation/range) between the ABR wave-I amplitude and the EFR magnitude as measured on the CochSyn test prototype with Snap electrodes in session 1.
Measured: end of session 1, after 3 hours
Secondary outcomes (14)
Usability CochSyn test prototype
Written feedback in form of a questionnaire of the test administrator on the usability of the test system for the measurements performed with the CochSyn test prototype during session 1.
Measured: end of session 1, after 3 hours
Performance CochSyn test prototype
The difference between the EFR magnitudes obtained with the CochSyn test prototype + cEEGrid electrodes and those obtained with the CochSyn test prototype + Snap electrodes measured for different stimulus carriers during session 1.
Measured: end of session 1, after 3 hours
Reliability Cochsyn test prototype
The difference between the EFR magnitudes during session 1 and session 2 (test/re-test). This concerns the recordings made with the CochSyn test prototype + cEEGrid and with the CochSyn test prototype + Snap electrodes.
Measured: end of session 2, after 2 hours
Sensitivity related to stimulus changes
The difference in magnitude between EFRs recorded for different stimulus carriers and for different stimulus levels on the CochSyn test prototype with Snap electrodes and the cEEGrid electrodes during session 1.
Measured: end of session 1, after 3 hours
Gender differences in EFR magnitude
The difference in EFR magnitude between men and woman of the cohort recorded on the CochSyn test prototype with Snap electrodes and the cEEGrid electrodes during session 1.
Measured: end of session 1, after 3 hours
Selectivity of EFR measurements
The difference between the EFR magnitudes of the control group and the test group for different stimulus carriers during session 1. Recordings are made on the CochSyn test prototype + Snap electrodes and differences will be assessed across the age-cohort as well as within each age group.
Measured: end of session 1, after 3 hours
Age-related decline in EFR magnitude
The correlation strength and regression slope of the EFR magnitudes with age obtained with the CochSyn test prototype + Snap electrodes measured at different carrier frequencies and sound levels during session 1 for the test subjects with or without self-reported hearing difficulties.
Measured: end of session 1, after 3 hours
Subjective hearing handicap
The correlation between the HHIE-s questionnaire score and the EFR magnitude at different carrier frequencies obtained with the CochSyn test prototype + Snap electrodes during session 1.
Measured: end of session 1, after 3 hours
Classification accuracy scale
Classification accuracy scale of correctly assigning a subject within a specific age group to have a subjective hearing handicap (based on HHIE-s) based on their EFR magnitude.
Measured: session 1, after 3 hours
Hearing thresholds
The correlation strength and regression slope of the EFR magnitude with the hearing threshold across the cohorts with and without self-reported hearing difficulties. Hearing thresholds related to standard clinical measures i.e., the pure-tone average from the audiogram with extended frequencies and distortion-product otoacoustic emission thresholds. EFR magnitudes at different carrier frequencies and sound levels during session 1 are considered.
Measured: end of session 1, after 3 hours
Speech intelligibility
The correlation strength and regression slope of the EFR magnitude with the speech reception threshold (objective marker of speech intelligibility, Matrix sentence test) across the cohorts with and without self-reported hearing difficulties. EFR magnitudes at different carrier frequencies and sound levels during session 1 are considered.
Measured: end of session 1, after 3 hours
Performance of CoNNear soundprocessing algorithm for normal audiograms
The speech reception threshold change (in dB) for subjects with low EFR magnitudes and normal audiograms that have received personalised CoNNear audio-processing to compensate for their low EFR magnitudes. The baseline situation is the speech reception threshold for unprocessed sound from session 2.
Measured: end of session 2, after 2,5 hours
Performance of CoNNear soundprocessing algorithm for impaired audiograms
The speech reception threshold change (in dB) for subjects with low EFR magnitudes and impaired audiograms that have received personalised CoNNear audio-processing to compensate for their low EFR magnitudes. The baseline situation is the speech reception threshold for unprocessed sound from session 2 and a standard sound processing algorithm.
Measured: end of session 2, after 2,5 hours
Sound quality rating of CoNNear soundprocessing algorithm
The difference in sound quality rating for the different CoNNear processing types compared to the unprocessed test material.
Measured: session 2, after 2,5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start13 Nov 2023
- Primary completion23 Dec 2025
- Study completion23 Dec 2025
Why it stopped: Delay in recruitment and funding exhausted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Sarah Verhulst, Prof., Study director, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114680
- Sponsor's protocol ID
- ONZ-2023-0258
- Acronym
- EarDiTech
- Status last verified
- Apr 2025
- First submitted
- 29 Sep 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the CochSyn Test Prototype to Measure Cochlear Synaptopathy
- ClinicalTrials.gov ID
- NCT06114680
- Acronym / sponsor ID
- EarDiTech / ONZ-2023-0258
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delay in recruitment and funding exhausted
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 2 Nov 2023 (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.
This study investigates a newly developed test, The CochSyn test that can quantify cochlear synaptopathy (CS) (a new type of sensorineural hearing loss (SNHL)) earlier than the current golden standard pure-tone audiogram.This newly developed test is based on auditory evoked brain potentials. A hardware prototype (the Cochsyn test prototype) was developed to use the Cochsyn test in clinical practice. Additionally a CS-based sound-processing algorithm (CoNNear) that is designed to improve speech intelligibility in subjects that are identified to have CS, will be investigated in this study.
Detailed description
Cochlear synaptopathy is a new type of sensorineural hearing loss (SNHL) and is related to ageing, noise exposure and ototoxicity. There is currently no diagnostic test of CS on the market, whereas CS is an important form of SNHL. CS occurs before the golden standard clinical hearing test (pure- tone audiogram in which participants raise their hand when hearing tones of different frequencies and the threshold of hearing is determined), shows any signs of hearing damage.
The investigators have developed a test, the CochSyn test that may quantify SNHL earlier than the audiogram. The newly developed test is based on auditory evoked potentials. This is a method in which an auditory stimulus is presented, and encephalogram (EEG) electrodes capture the sound-evoked brain potentials. The most popular auditory evoked potential metric to diagnose sensorineural hearing loss (SNHL) is the auditory brainstem response (ABR). The first animal research studies on CS confirmed that the ABR wave-I amplitude is a sensitive marker of CS when the inflicted hearing damage is well-controlled and specific. Even though it can be assumed that the ABR wave-I amplitude will also be sensitive to CS in humans, it may not be a differential marker for it, and hence other candidate auditory evoked potential markers for CS have been investigated in recent studies. In particular, the envelope-following-response (EFR), has also been shown to be specific to CS in animal research studies.
EFRs are recorded using the standard ABR electrode montage but use another type of stimulus. Based on model simulations and a recent study in which the investigators compared candidate EFR markers for use in human studies , the investigators have developed a new stimulus for EFRs that uses both a different type of modulator waveform and a different analysis method than was adopted earlier.
In this trial, the investigators wish to test the performance of the new method (the CochSyn test) in listeners with or without self-reported hearing difficulties using a newly developed hardware prototype (the CochSyn test prototype), dedicated for the CochSyn-test in clinical practice. The assessment also includes the testing of a CS-based sound-processing algorithm (CoNNear) that is designed to improve speech intelligibility in subjects that are identified to have CS, based on our CochSyn test.
To this end, the investigators will first assess whether our CochSyn test prototype is equally good at capturing the standard ABR waveform as a comparator device available on the market (the Intelligent Hearing Systems Universal Smart Box). The investigators will also test which stimulation characteristics and electrode configurations for the CochSyn test are best able to quantify individual differences in standard objective hearing tests (audiogram, otoacoustic emission, speech reception thresholds) and subjective hearing complaints (validated HHIE-s questionnaire).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Session 1 - test group (self-reported hearing difficulties) | Other | Device: CochSyn test prototype, Device: Universal Smart Box (USB)143 (130 + 10% potential drop-outs) subjects with self-reported hearing difficulties according to the HHIE-s questionnaire (score of >4) |
| Session 1 - control goup (no self-reported hearing difficulties) | Other | Device: CochSyn test prototype, Device: Universal Smart Box (USB)66 (60 + 10% potential drop-outs) subjects with no self-reported hearing difficulties according to HHIE-s questionnaire (score of ≤4) |
| Session 2 (self-reported hearing difficulties) | Other | Device: CochSyn test prototype66 (60 + 10% potential drop-outs) subjects who participated in session 1 - test group |
Who may qualify
- Ages
- 18 to 87 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Session 1
- Test group
- 18 - 87 years old
- Flemish/Dutch as native language
- Ability to fill out a questionnaire and to perform a speech intelligibility test
Key exclusion criteria (8 listed)
- Pregnant woman
- Breastfeeding woman
- Chronic (longer than 6 months) permanent tinnitus
- Hearing loss due to a genetic condition, a middle ear condition, or surgery
- Congenital hearing loss
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 |
|---|---|---|
| CochSyn test prototypeThe CochSyn test prototype is intended for use in the evaluation of hearing-related disorders in adults using auditory evoked potentials. The CochSyn test prototype records biopotential waveforms that can be used for hearing screening and diagnostic applications. | Device | Session 1 - control goup (no self-reported hearing difficulties), Session 1 - test group (self-reported hearing difficulties), Session 2 (self-reported hearing difficulties) |
| Universal Smart Box (USB)Commercially available EEG system intended for use in the diagnosis of hearing related disorders, hearing threshold detection, and other conditions that may affect the responses to auditory, tactile, or visual stimuli. The USB Box hardware and accompanying software programs can be used with patients of all ages. It is intended for use by trained personnel in a hospital, nursery, clinic, audiologist's office, or other appropriate setting. | Device | Session 1 - control goup (no self-reported hearing difficulties), Session 1 - test group (self-reported hearing difficulties) |
Primary outcome
Quality of Cochsyn test prototype
Time frame: end of session 1, after 3 hours
The difference in terms of wave amplitudes of a standard clinical auditory brainstem response (ABR) recorded with the commercially available USB device and with the CochSyn test prototype during session 1.
Sensitivity CochSyn test prototype
Time frame: end of session 1, after 3 hours
The difference in sensitivity (i.e., standard deviation/range) between the ABR wave-I amplitude and the EFR magnitude as measured on the CochSyn test prototype with Snap electrodes in session 1.
14 secondary outcomes
Usability CochSyn test prototype
Time frame: end of session 1, after 3 hours
Performance CochSyn test prototype
Time frame: end of session 1, after 3 hours
Reliability Cochsyn test prototype
Time frame: end of session 2, after 2 hours
Sensitivity related to stimulus changes
Time frame: end of session 1, after 3 hours
Gender differences in EFR magnitude
Time frame: end of session 1, after 3 hours
Selectivity of EFR measurements
Time frame: end of session 1, after 3 hours
Age-related decline in EFR magnitude
Time frame: end of session 1, after 3 hours
Subjective hearing handicap
Time frame: end of session 1, after 3 hours
Classification accuracy scale
Time frame: session 1, after 3 hours
Hearing thresholds
Time frame: end of session 1, after 3 hours
Speech intelligibility
Time frame: end of session 1, after 3 hours
Performance of CoNNear soundprocessing algorithm for normal audiograms
Time frame: end of session 2, after 2,5 hours
Performance of CoNNear soundprocessing algorithm for impaired audiograms
Time frame: end of session 2, after 2,5 hours
Sound quality rating of CoNNear soundprocessing algorithm
Time frame: session 2, after 2,5 hours
Results and safety
The study was stopped early (reason given: Delay in recruitment and funding exhausted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sarah Verhulst, Prof. study director
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CochSyn test prototype and Universal Smart Box (USB) in people with Hearing Loss, Sensorineural and Cochlear Synaptopathy, run by University Ghent at 1 site in Belgium.
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 17 inclusion and 8 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: stopped early, as of the sponsor's last update on 10 Feb 2026. 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 Belgium. 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?
The study was stopped early (reason given: Delay in recruitment and funding exhausted). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Cochsyn test prototype (time frame: end of session 1, after 3 hours). 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 10 Feb 2026.