Measuring speech intelligibility in children with hearing loss using brain wave recordings
Automated Measures of Speech Intelligibility Using Brain Wave Recordings
This study is testing a new software that uses brain wave recordings to see how well children with hearing loss can understand speech while using hearing aids.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 0 Years to 12 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 4 sites (Gent, Oost-Vlaanderen and 3 other locations) |
| Trial ID | NCT06402994 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy of the CORGEE software, which uses brain wave recordings to assess speech intelligibility in children with suspected hearing impairment. The study will involve 90 children aged 0 to 12 years, who will undergo objective assessments of their speech intelligibility while using hearing aids. The results will be compared to traditional behavioral measures to determine the software's clinical validity. The study will take place across four sites over a 12-month period.
Who should consider this trial
Good fit: Ideal candidates include children aged 0 to 12 years with bilateral hearing loss or suspected hearing loss who are using hearing aids.
Not a fit: Patients without hearing loss or those who do not use hearing aids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more objective and effective method for assessing hearing aid benefits in children, leading to better treatment outcomes.
How similar studies have performed: While the approach of using EEG for assessing speech intelligibility is innovative, similar studies have shown promise in related fields, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gent, Oost-Vlaanderen and 3 other locations
- CAR Sint-Lievenspoort — Gent, Oost-Vlaanderen, Belgium (Not_yet_recruiting)
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
- CAR Overleie — Kortrijk, West-Vlaanderen, Belgium (Completed)
- KOCA vzw — Antwerpen, Belgium (Recruiting)
Study contacts
- Study coordinator: Tom Francart, Prof.
- Email: tom.francart@kuleuven.be
- Phone: +3216379840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.