TerminatedNot Applicable

Evaluation of the CochSyn Test Prototype to Measure Cochlear Synaptopathy

Stopped: Delay in recruitment and funding exhausted

Belgium179 participantsStarted 2023-11-13

Plain-language 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.

Who can participate

Age range

18 Years – 87 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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) * 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) Exclusion Criteria: 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 tinni…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quality of Cochsyn test prototype

Timeframe: end of session 1, after 3 hours

Sensitivity CochSyn test prototype

Timeframe: end of session 1, after 3 hours

Trial details

NCT IDNCT06114680

SponsorUniversity Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-23

View on ClinicalTrials.gov More Hearing Loss, Sensorineural trials