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Search / Trial NCT06402994

Automated Measures of Speech Intelligibility Using Brain Wave Recordings

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · May 2, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Speech Intelligibility Eeg Objective Measure Hearing Loss Hearing Aid Benefit Children

ClinConnect Summary

This clinical trial, called CORGEE, is studying a new way to measure how well children with hearing loss understand speech using brain wave recordings. Hearing loss is quite common, especially among children, and if not addressed early, it can lead to challenges in communication and learning. The current tests often require children to respond to sounds in specific ways, which can be difficult for younger kids or those who can’t communicate well. The CORGEE study aims to use a method called "neural speech tracking," which looks at brain waves to see how well children understand speech without needing them to actively participate in the testing.

The trial is open to children aged 0 to 12 years who have been diagnosed with hearing loss and are using hearing aids. To participate, parents or guardians will need to provide consent, and the child should be able to understand some Dutch. Children will undergo tests that measure their speech understanding through brain activity in a supportive environment. This research is important because it could lead to better ways to assess hearing in young children, helping to ensure they receive the support they need for their speech and language development.

Gender

ALL

Eligibility criteria

  • 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

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, , Belgium

Leuven, Vlaams Brabant, Belgium

Gent, Oost Vlaanderen, Belgium

Kortrijk, West Vlaanderen, Belgium

Antwerpen, , Belgium

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported