NCT06114680

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

November 13, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2025

Completed
Last Updated

February 10, 2026

Status Verified

April 1, 2025

Enrollment Period

2.1 years

First QC Date

September 29, 2023

Last Update Submit

February 6, 2026

Conditions

Hearing Loss, SensorineuralCochlear SynaptopathyCochlear Hearing Loss

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    end of session 1, after 3 hours

Secondary Outcomes (14)

  • Usability CochSyn test prototype

    end of session 1, after 3 hours

  • Performance CochSyn test prototype

    end of session 1, after 3 hours

  • Reliability Cochsyn test prototype

    end of session 2, after 2 hours

  • Sensitivity related to stimulus changes

    end of session 1, after 3 hours

  • Gender differences in EFR magnitude

    end of session 1, after 3 hours

  • +9 more secondary outcomes

Study Arms (3)

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)

Device: CochSyn test prototypeDevice: 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)

Device: CochSyn test prototypeDevice: 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

Device: CochSyn test prototype

Interventions

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.

Session 1 - control goup (no self-reported hearing difficulties)Session 1 - test group (self-reported hearing difficulties)
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.

Session 1 - control goup (no self-reported hearing difficulties)Session 1 - test group (self-reported hearing difficulties)Session 2 (self-reported hearing difficulties)

Eligibility Criteria

Age18 Years - 87 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Session 1
  • Test group
  • 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
  • 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
  • +2 more criteria

You may not qualify if:

  • Applicable for both sessions:
  • 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
  • Blocked ear canal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Gent - department of otorhinolaryngology

Ghent, 9000, Belgium

Location

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

September 29, 2023

First Posted

November 2, 2023

Study Start

November 13, 2023

Primary Completion

December 23, 2025

Study Completion

December 23, 2025

Last Updated

February 10, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)