Status:
RECRUITING
Evaluation of the CochSyn Test Prototype to Measure Cochlear Synaptopathy
Lead Sponsor:
University Ghent
Collaborating Sponsors:
University Hospital, Ghent
Conditions:
Hearing Loss, Sensorineural
Cochlear Synaptopathy
Eligibility:
All Genders
18-87 years
Phase:
NA
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...
Detailed Description
Cochlear synaptopathy is a new type of sensorineural hearing loss (SNHL) and is related to ageing, noise exposure and ototoxicity. There is currently no diagnostic test of CS on the market, whereas CS...
Eligibility Criteria
Inclusion
- 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
- 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
- Hearing loss due to a genetic condition, a middle ear condition, or surgery
- Congenital hearing loss
- Blocked ear canal
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT06114680
Start Date
November 13 2023
End Date
January 31 2026
Last Update
May 1 2025
Active Locations (1)
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1
UZ Gent - department of otorhinolaryngology
Ghent, Belgium, 9000