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Brain wave test could revolutionize hearing checks for children

NCT ID NCT06402994

Diagnosis Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study tested a new method called CORGEE that uses brain wave recordings (EEG) to measure how well children with hearing loss understand speech. Unlike standard hearing tests that require kids to respond verbally, this approach is objective and does not need active participation. The goal is to improve early diagnosis and treatment for children who cannot communicate clearly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Electroencephalography (EEG) and CORGEE software
What this could lead to
If successful, this could lead to an objective hearing test that measures speech understanding in children who cannot respond verbally.
What could go wrong
This is a small, completed study focused on validating the method. It may not translate into a widely available clinical tool, and brain wave recordings can be affected by movement or attention.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

100 people

The number who actually took part.

Started

Feb 2024

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Children with a bilateral hearing impairment in Flanders

Ages

0 to 12 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subcategory 1 (Infants \& toddlers) * 0 - 2,5 years of age * Bilateral hearing loss OR * Suspicion of hearing loss (at least 1 criteria met): referred after FAIL on the new born hearing screening OR referred by the subject's paediatrician, general practitioner or otolaryngologist * Voluntary written informed consent of the legally authorised representative 2. Subcategory 2 (Kindergartners) * 2,5 - 6 years of age * Going to kindergarten * Bilateral hearing loss * Using hearing aids regularly for at least three months * Would be cooperative in behavioural testing * Knowledge of Dutch (at least 1 criteria met): Dutch as mother tongue OR enrolled in Dutch speaking education * Voluntary written informed consent of the legally authorised representative 3. Subcategory 3 (Primary school children) * 6 - 12 years of age * Going to primary school * Bilateral hearing loss * Using hearing aids regularly for at least three months * Would be cooperative in behavioural testing * Knowledge of Dutch (at least 1 criteria met): Dutch as mother tongue OR enrolled in Dutch speaking education * Voluntary written informed consent of the legally authorised representative Exclusion Criteria: * no exposure to Dutch * known brain injuries * acute illness

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Conditions

The condition(s) this trial relates to.

hearing loss disorder Speech Intelligibility

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hearing disorders in children Hearing loss

Contacts and locations

Locations

  • CAR Overleie

    Kortrijk, West-Vlaanderen, 8500, Belgium

  • CAR Sint-Lievenspoort

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • KOCA vzw

    Antwerp, Antwerpen, 2018, Belgium

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000, Belgium

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