Evaluation of the CochSyn Test Prototype to Measure Cochlear Synaptopathy
Key facts
- Who runs it
- University Ghent
- Where
- Belgium1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 179 people enrolled
- Started
- 13 Nov 2023
- Ended
- 23 Dec 2025
- Type of study
- Interventional, 3 groups
- Treatments tested
- CochSyn test prototype
- Universal Smart Box (USB)
- Record updated
- 10 February 2026
- Why it stopped
- Delay in recruitment and funding exhausted
Who can take part
- Age
- 18 years to 87 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Hearing loss due to a genetic condition, a middle ear condition, or surgery
- 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 tinnitus
- Congenital hearing loss
- Blocked ear canal
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Session 1 - test group (self-reported hearing difficulties)Other group
143 (130 + 10% potential drop-outs) subjects with self-reported hearing difficulties according to the HHIE-s questionnaire (score of \>4)
Treatment: CochSyn test prototype and Universal Smart Box (USB)
- Session 1 - control goup (no self-reported hearing difficulties)Other group
66 (60 + 10% potential drop-outs) subjects with no self-reported hearing difficulties according to HHIE-s questionnaire (score of ≤4)
Treatment: CochSyn test prototype and Universal Smart Box (USB)
- Session 2 (self-reported hearing difficulties)Other group
66 (60 + 10% potential drop-outs) subjects who participated in session 1 - test group
Treatment: CochSyn test prototype
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 10 February 2026