New test to measure early signs of hearing loss

Evaluation of the CochSyn Test Prototype to Measure Cochlear Synaptopathy

This study is testing a new hearing test that aims to spot early signs of hearing loss before regular tests do, to help people understand their hearing better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 209 (estimated)
• Ages: 18 Years to 87 Years
• Sex: All
• Sponsor: University Ghent (Academic / other)
• Locations: 1 site (Gent)
• Trial ID: NCT06114680 on ClinicalTrials.gov

What this trial studies

This study evaluates the CochSyn test prototype, which aims to quantify cochlear synaptopathy (CS), a type of sensorineural hearing loss, earlier than traditional audiograms. The test utilizes auditory evoked brain potentials to detect CS, which can occur before standard hearing tests show damage. Additionally, the study will investigate a sound-processing algorithm designed to enhance speech intelligibility for individuals identified with CS. Participants will undergo assessments to determine their eligibility based on hearing ability and language proficiency.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 87 who are native Flemish/Dutch speakers and have self-reported hearing difficulties or normal audiograms.

Not a fit: Patients with severe hearing loss or those who do not speak Flemish/Dutch may not benefit from this study.

Why it matters

Potential benefit: If successful, this test could lead to earlier diagnosis and intervention for individuals with cochlear synaptopathy, potentially improving their hearing outcomes.

How similar studies have performed: While the CochSyn test is a novel approach, preliminary animal studies have shown promise in identifying cochlear synaptopathy using auditory evoked potentials.

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

Where this trial is running

Gent

• UZ Gent - department of otorhinolaryngology — Gent, Belgium (Recruiting)

Study contacts

• Study coordinator: Sarah Verhulst

Conditions Hearing Loss, Sensorineural; Cochlear Synaptopathy; Cochlear Hearing Loss