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 range18 Years – 87 Years

SexALL

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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…

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