Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
73 participants
INTERVENTIONAL
2025-10-29
2025-12-31
Brief Summary
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Detailed Description
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The sponsor has developed a new 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). Even though it can be assumed that the ABR wave-I amplitude will 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 particular, the envelope-following-response (EFR), has also been shown to be specific to CS.
The sponsor has performed several research studies on the CochSyn test that used commercially available research equipment in either humans or research animals . These data show that our marker is sensitive to ototoxic-induced CS in research animals and demonstrates an age-related decline in humans, and a superiority in terms of test-retest reliability and sensitivity compared to clinical ABR wave-I, or other evoked potential, markers. These promising data, the lack of a method to identify CS and the lack of commercially available hardware to conduct the CochSyn test in a clinical setting motivate the need for the development of the CochSyn test and device.
In this study, the sponsor wish to test the performance of its new method (the CochSyn test) in listeners with or without self-reported hearing difficulties using a newly developed hardware prototype (the CochSyn device), dedicated for the CochSyn test in clinical practice.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Control group (no self-reported hearing difficulties)
30 subjects without self-reported hearing difficulties according to the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-s) questionnaire (score of ≤4)
CochSyn device
The CochSyn device is intended for use in the evaluation of hearing-related disorders in adults using auditory evoked potentials. The CochSyn device records and analyses biopotential waveforms that can be used for hearing screening and diagnostic applications.
DeaFNess Autosomal dominant 9 (DFNA9) subgroup (genetically tested and confirmed)
10 subjects (+3 potential drop-outs) genetically tested and confirmed to have DeaFNess Autosomal dominant 9 (DFNA9) related hearing loss
CochSyn device
The CochSyn device is intended for use in the evaluation of hearing-related disorders in adults using auditory evoked potentials. The CochSyn device records and analyses biopotential waveforms that can be used for hearing screening and diagnostic applications.
Test group (self-reported hearing difficulties)
30 subjects with self-reported hearing difficulties according to the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-s) questionnaire (score of \>4)
CochSyn device
The CochSyn device is intended for use in the evaluation of hearing-related disorders in adults using auditory evoked potentials. The CochSyn device records and analyses biopotential waveforms that can be used for hearing screening and diagnostic applications.
Interventions
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CochSyn device
The CochSyn device is intended for use in the evaluation of hearing-related disorders in adults using auditory evoked potentials. The CochSyn device records and analyses biopotential waveforms that can be used for hearing screening and diagnostic applications.
Eligibility Criteria
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Inclusion Criteria
* Ability to fill out a questionnaire and to perform a speech intelligibility test
* Dutch or French as native language
• Control group
* No self-reported hearing difficulties according to HHIE-s questionnaire (score of ≤4)
• Test group
* Self-reported hearing difficulties according to HHIE-s questionnaire (score of \>4)
• Subgroup DFNA9:
* Genetically tested and confirmed to have DFNA9 related hearing loss. Note: This genetic testing was performed through standard of care testing, prior to participation in the study.
Exclusion Criteria
* Asymmetrical hearing loss Note 1: Asymmetrical hearing loss is defined as an average difference of more than 15dB between both ears across the frequencies of 500, 1000, 2000 and 4000 Hz. The sum of loss in dB is divided by 4 and rounded up. A frequency not perceived is considered a loss of 120 dB.
Note 2: This exclusion criterium is not applicable for the DFNA 9 subgroup
* Tinnitus with a clinical handicap index (TFI) \> 25.
* Patients with type AD, AS, B or C tympanograms
* Conductive hearing loss on the tested ear at the discretion of the investigator
* Genetic hearing loss of the tested ear Note: This exclusion criterium is not applicable for the DFNA9 subgroup.
* Congenital hearing loss of the tested ear Note: This exclusion criterium is not applicable for the DFNA9 subgroup.
* Blocked ear canal(s) of the tested ear
* Pregnant or breast-feeding
* Hearing aid user on the tested ear
* Middle ear surgery on the tested ear
* Acute ear infection of the tested ear
* Acute external auditory canal trauma on the tested ear
* Participation in session 2 of previous clinical trial NCT06114680
18 Years
77 Years
ALL
Yes
Sponsors
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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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University Hospital Antwerp (UZA)
Antwerp, , Belgium
University Hospital Ghent
Ghent, , Belgium
CHU de Liège
Liège, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Marc Lammers
Role: primary
Ingeborg Dhooge
Role: primary
Séverine Camby
Role: primary
References
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van de Pol M, Verhulst S. Age-dependent traits: a new statistical model to separate within- and between-individual effects. Am Nat. 2006 May;167(5):766-73. doi: 10.1086/503331. Epub 2006 Mar 20.
Garrett M, Verhulst S. Applicability of subcortical EEG metrics of synaptopathy to older listeners with impaired audiograms. Hear Res. 2019 Sep 1;380:150-165. doi: 10.1016/j.heares.2019.07.001. Epub 2019 Jul 2.
Keshishzadeh S, Garrett M, Verhulst S. Towards Personalized Auditory Models: Predicting Individual Sensorineural Hearing-Loss Profiles From Recorded Human Auditory Physiology. Trends Hear. 2021 Jan-Dec;25:2331216520988406. doi: 10.1177/2331216520988406.
S. Verhulst, H. Van Der Biest, S. Keshishzadeh, H. Keppler, and I. Dhooge, "Supra-threshold envelope-following responses in the ageing population : an early marker of sensorineural hearing damage," in JOURNAL OF THE ACOUSTICAL SOCIETY OF AMERICA, Chicago, IL, USA, 2023, vol. 153, no. 3, Supplement, pp. A50-A50.
N. De Poortere, W. Van Ransbeeck, S. Keshishzadeh, H. Keppler, I. Dhooge, and S. Verhulst, "Music festivals : the effect of recreational noise exposure on young adults hearing," in ARO (Association for Research in Otolaryngology) 46th Annual Midwinter Conference, Abstracts, Orlando, Florida, 2023.
H. Van Der Biest, H. Keppler, I. Dhooge, S. Keshishzadeh, and S. Verhulst, "Cochlear synaptopathy in the ageing population," in 13th Speech in Noise Workshop, Abstracts, online, 2022.
Verhulst S, Altoe A, Vasilkov V. Computational modeling of the human auditory periphery: Auditory-nerve responses, evoked potentials and hearing loss. Hear Res. 2018 Mar;360:55-75. doi: 10.1016/j.heares.2017.12.018. Epub 2017 Dec 28.
Vasilkov V, Caswell-Midwinter B, Zhao Y, de Gruttola V, Jung DH, Liberman MC, Maison SF. Evidence of cochlear neural degeneration in normal-hearing subjects with tinnitus. Sci Rep. 2023 Nov 30;13(1):19870. doi: 10.1038/s41598-023-46741-5.
Other Identifiers
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ONZ-2025-0104
Identifier Type: -
Identifier Source: org_study_id