NCT07091071

Brief Summary

This study investigates a new type of auditory evoked brain potentials for the quantification and classification of peripheral hearing damage (The CochSyn Test). The study will investigate the characteristics of this new auditory evoked potential marker in a cohort of people with and without self-reported hearing difficulties and test a new type of hardware that was developed to conduct the test (the CochSyn Device) in clinical practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 29, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2026

Completed
Last Updated

February 10, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

July 10, 2025

Last Update Submit

February 6, 2026

Conditions

Hearing Loss, SensorineuralCochlear Hearing LossCochlear SynaptopathyDFNA9

Keywords

Auditory Evoked PotentialsEnvelope Following ResponseAuditory Brainstem ResponseHearing Difficulties

Outcome Measures

Primary Outcomes (6)

  • Clinical performance CochSyn device: speech intelligibility

    A significant multiple regression model that predicts speech intelligibility (quantified using the speech reception threshold) based on markers of hearing

    Through study completion, an average of 2,5 hours

  • Clinical performance CochSyn device: self-reported hearing difficulties

    A significant multiple regression model that predicts self-reported hearing difficulties (quantified using the Hearing Handicap Inventory for the Elderly - Screening Version questionnaire) based on markers of hearing. HHIE-s score varies from 0 to 40. The higher the score the higher probability of hearing impairment.

    Through study completion, an average of 2,5 hours

  • Reliability of the CochSyn test

    The difference between the EFR measure in a test-retest setting, where the same measurement is performed twice during the experiment.

    Through study completion, an average of 2,5 hours

  • Device related safety events of the CochSyn device

    The cumulative rate of device related safety events throughout the study.

    Through study completion, an average of 2,5 hours

  • Technical performance of the CochSyn device

    The cumulative rate of device deficiencies throughout the study.

    Through study completion, an average of 2,5 hours

  • Usability of the CochSyn device

    Written feedback in form of a questionnaire and subjective comments of the test administrator on the usability of the test system for the measurements performed with the CochSyn Device after a measurement session, with regard to ease of use and comfort for both the clinician and the patient.

    Through study completion, an average of 2,5 hours

Study Arms (3)

Test group (self-reported hearing difficulties)

EXPERIMENTAL

30 subjects with self-reported hearing difficulties according to the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-s) questionnaire (score of \>4)

Device: CochSyn device

Control group (no self-reported hearing difficulties)

EXPERIMENTAL

30 subjects without self-reported hearing difficulties according to the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-s) questionnaire (score of ≤4)

Device: CochSyn device

DeaFNess Autosomal dominant 9 (DFNA9) subgroup (genetically tested and confirmed)

EXPERIMENTAL

10 subjects (+3 potential drop-outs) genetically tested and confirmed to have DeaFNess Autosomal dominant 9 (DFNA9) related hearing loss

Device: CochSyn device

Interventions

CochSyn deviceDEVICE

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.

Control group (no self-reported hearing difficulties)DeaFNess Autosomal dominant 9 (DFNA9) subgroup (genetically tested and confirmed)Test group (self-reported hearing difficulties)

Eligibility Criteria

Age18 Years - 77 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-77 years (limits included)
  • 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.

You may not qualify if:

  • Audiometric hearing loss classifications of Moderate, Moderately severe, Severe, Profound as defined by (Clark, 1981) of the tested ear
  • 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.
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Antwerp (UZA)

Antwerp, Belgium

Location

University Hospital Ghent

Ghent, Belgium

Location

CHU de Liège

Liège, Belgium

Location

Related Publications (8)

  • 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.

    PMID: 16671020BACKGROUND

  • 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.

    PMID: 31306930BACKGROUND

  • 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.

    PMID: 33526004BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 29472062BACKGROUND

  • 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.

    PMID: 38036538BACKGROUND

MeSH Terms

Conditions

Hearing Loss, SensorineuralHearing Loss, Hidden

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah Verhulst, Prof.

    University Ghent

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 29, 2025

Study Start

October 29, 2025

Primary Completion

January 22, 2026

Study Completion

January 22, 2026

Last Updated

February 10, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(3)