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Evaluation of the CochSyn Test Prototype to Measure Cochlear Synaptopathy

NCT06114680 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

  • Hearing Loss, Sensorineural
  • Cochlear Synaptopathy
  • Cochlear Hearing Loss

Interventions

DEVICE

CochSyn test prototype

The CochSyn test prototype is intended for use in the evaluation of hearing-related disorders in adults using auditory evoked potentials. The CochSyn test prototype records biopotential waveforms that can be used for hearing screening and diagnostic applications.

DEVICE

Universal Smart Box (USB)

Commercially available EEG system intended for use in the diagnosis of hearing related disorders, hearing threshold detection, and other conditions that may affect the responses to auditory, tactile, or visual stimuli. The USB Box hardware and accompanying software programs can be used with patients of all ages. It is intended for use by trained personnel in a hospital, nursery, clinic, audiologist's office, or other appropriate setting.

Sponsors & Collaborators

  • University Hospital, Ghent

    collaborator OTHER

  • University Ghent

    lead OTHER

Principal Investigators

  • Sarah Verhulst, Prof. · University Ghent

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
87 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-13
Primary Completion
2025-12-23
Completion
2025-12-23

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06114680 on ClinicalTrials.gov