Evaluation of the CochSyn Test Prototype to Measure Cochlear Synaptopathy

Launched by UNIVERSITY GHENT · Oct 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new test called the CochSyn test, which aims to measure a specific type of hearing loss known as cochlear synaptopathy (CS). This condition affects how well our ears and brain work together to process sound, and it can be detected earlier with this new test compared to the standard hearing tests currently used. The CochSyn test uses a special method to record brain responses to sounds, which can help identify individuals who might have this type of hearing loss. Additionally, the study will explore a new sound-processing tool called CoNNear, designed to help people with CS better understand speech.

To participate in this trial, you need to be between 18 and 87 years old and speak Flemish or Dutch. You should also have some difficulty hearing, as indicated by a questionnaire, or have normal hearing test results. Participants will undergo speech tests and complete a questionnaire. Importantly, pregnant or breastfeeding women, as well as individuals with certain types of hearing loss or ear conditions, are not eligible for this study. If you choose to take part, you can help researchers learn more about cochlear synaptopathy and improve future treatments for hearing loss.

Gender

ALL

Eligibility criteria

• 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 tinnitus
• • Hearing loss due to a genetic condition, a middle ear condition, or surgery
• • Congenital hearing loss
• • Blocked ear canal