Evaluation of the CochSyn Test Prototype to Measure Cochlear Synaptopathy
NCT ID: NCT06114680
Last Updated: 2026-02-10
Study Results
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Basic Information
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TERMINATED
NA
179 participants
INTERVENTIONAL
2023-11-13
2025-12-23
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Session 1 - test group (self-reported hearing difficulties)
143 (130 + 10% potential drop-outs) subjects with self-reported hearing difficulties according to the HHIE-s questionnaire (score of \>4)
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.
CochSyn test prototype
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.
Session 1 - control goup (no self-reported hearing difficulties)
66 (60 + 10% potential drop-outs) subjects with no self-reported hearing difficulties according to HHIE-s questionnaire (score of ≤4)
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.
CochSyn test prototype
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.
Session 2 (self-reported hearing difficulties)
66 (60 + 10% potential drop-outs) subjects who participated in session 1 - test group
CochSyn test prototype
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.
Interventions
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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.
CochSyn test prototype
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.
Eligibility Criteria
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Inclusion Criteria
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)
* 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)
* 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
Exclusion Criteria
* Pregnant woman
* Breastfeeding woman
18 Years
87 Years
ALL
Yes
Sponsors
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University Hospital, Ghent
OTHER
University Ghent
OTHER
Responsible Party
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Principal Investigators
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Sarah Verhulst, Prof.
Role: STUDY_DIRECTOR
University Ghent
Locations
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UZ Gent - department of otorhinolaryngology
Ghent, , Belgium
Countries
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Other Identifiers
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ONZ-2023-0258
Identifier Type: -
Identifier Source: org_study_id
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