Hearing Disorders in ChildrenCORGEENCT06402994
Automated Measures of Speech Intelligibility Using Brain Wave Recordings
An observational study of Hearing Disorders in Children and Hearing Loss, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in Belgium.
Trial summary
Hearing loss is one of the most prevalent impairments in the world. The World Health Organization estimates that as of 2020, around 466 million people worldwide are affected by disabling hearing loss, of which 34 million are children. Read more about this study
- Who is it for?
- Ages 0 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Disorders in Children, Hearing Loss
- What is being tested?
- Electrophysiological experiment and Speech audiometry
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 4 sitesBelgium
- Study dates
- 28 Feb 2024to 23 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with a bilateral hearing impairment in Flanders
Who may be able to join
- 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
- Subcategory 2 (Kindergartners)
Show all 21Show fewer
- 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
- 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
Who cannot join
- no exposure to Dutch
- known brain injuries
- acute illness
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
KOCA vzw
Antwerp, Antwerpen, 2018
CAR Sint-Lievenspoort
Ghent, Oost-Vlaanderen, 9000
CAR Overleie
Kortrijk, West-Vlaanderen, 8500
UZ Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Hearing loss is one of the most prevalent impairments in the world. The World Health Organization estimates that as of 2020, around 466 million people worldwide are affected by disabling hearing loss, of which 34 million are children. Without appropriate diagnosis and treatment, hearing impairment can cause difficulties with communication, learning, social-emotional functioning, employment and quality of life. Early intervention is especially important for children, for whom unaddressed hearing loss has been proven to affect speech and language development, educational attainments, and social skills. Through early detection and interventions many of these impacts can be mitigated, highlighting the importance of accurate hearing diagnostics.
Evaluation of speech intelligibility is a fundamental component of hearing assessment and rehabilitation. The current gold standard in measuring speech intelligibility relies heavily on behavioural tests. While these tests are reliable and fast in healthy adults, it is challenging to assess speech intelligibility for patients who cannot communicate clearly, such as young children. For example, behavioral tests require active participation from the patient, such as raising their hand when a sound is heard, or repeating words and sentences.
Read more
Objective measures, for instance using electro-encephalography (EEG), could overcome the current challenges in hearing assessment and do not require active participation from the patient. For example, in Flanders, all newborns are screened with an objective test where a few sensors on the head detect brainwaves in response to sounds. However, objective tests only use simple sound stimuli, such as tones or clicks, which cannot be used to measure important high-level hearing outcomes, such as speech understanding. In other words, current objective tests are used to check if a person can hear a word, but they can't indicate if the person can understand the word.
An obvious missing link in audiological practice is a diagnostic test that can measure high-level hearing outcomes such as speech understanding in an objective way. For this reason, CORGEE was developed. CORGEE uses a novel method of "neural speech tracking" to objectively measure speech intelligibility using EEG. In the current study, the efficacy and the clinical validity of the CORGEE software will be evaluated in young children with a hearing impairment.
Read the detailed description
This study is set-up as a pre-market clinical investigation of a non-CE marked medical device. The main goal of the study is to measure the efficacy of the CORGEE software, a newly developed software application that will function as an added service in the auditory assessment and counselling by hearing care professionals for persons with (suspected) hearing-related problems.
We will evaluate the efficacy and the clinical validity of the CORGEE software by means of a within-subject cross-sectional study in infants, toddlers, kindergartners and primary school children. The study will be carried out in 90 children with (suspected) hearing impairment. Participants are recruited via four participating sites (one university hospital and three ambulatory revalidation centers) across a period of 12 months.
All participants will undergo an objective assessment of speech intelligibility based on electrophysiological responses to natural running speech, performed by their healthcare professional (HCP). Using the CORGEE device, neural tracking of the speech envelope will be investigated with and without hearing aids at different levels of speech intelligibility. With this clinical study, we aim to demonstrate an objective hearing aid benefit when listening to natural speech using EEG. Moreover, we aim to compare the objective results with behavioural measures of speech intelligibility obtained with standard-of-care assessments (speech audiometry). Additionally, by means of questionnaires we aim to determine the HCP's evaluation of the level of tolerance of the assessment for children, as well as the HCP's user experience and satisfaction with the CORGEE software. Finally, we will assess the usability of the CORGEE software as a counselling tool for persons with (suspected) hearing-related problems and their caregivers.
- Conditions
- Hearing Disorders in Children, Hearing Loss
- Being tested
- Electrophysiological experiment, Speech audiometry
- Keywords
- speech intelligibility, EEG, objective measure, hearing loss, hearing aid benefit, children
- Medical subject headings
- Hearing Loss, Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiological experimentOther
Also called Use of the CORGEE software
Neural envelope tracking to conversational speech at different intensities
Speech audiometryBehavioural
Speech perception assessment at different intensities
| Study group | Role | What they receive |
|---|---|---|
| Infants & toddlers | Children between 0 and 2,5 years of age Receives: Other: Electrophysiological experiment | |
| Kindergartners | Children between 2,5 and 6 years of age Receives: Other: Electrophysiological experiment; Behavioral: Speech audiometry | |
| Primary school children | Children between 6 and 12 years of age Receives: Other: Electrophysiological experiment; Behavioral: Speech audiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural speech tracking
Neural envelope tracking to conversational speech at different intensities. Here, neural envelope tracking represents the correlation between the original envelope (i.e. the envelope of the presented speech signal) and the reconstructed envelope (i.e., the envelope as calculated from the EEG)
Measured: Baseline
Secondary outcomes (1)
Speech intelligibility
Speech intelligibility of three-phoneme consonant-vowel-consonant (CVC) words at different intensities.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start28 Feb 2024
- Primary completion23 Jun 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Disorders in ChildrenStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402994
- Sponsor's protocol ID
- S67892
- Other IDs
- CIV-23-08-043833
- Acronym
- CORGEE
- Status last verified
- Sep 2025
- First submitted
- 22 Apr 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Measures of Speech Intelligibility Using Brain Wave Recordings
- ClinicalTrials.gov ID
- NCT06402994
- Acronym / sponsor ID
- CORGEE / S67892
- Conditions
- Hearing Disorders in Children, Hearing Loss
- Keywords
- speech intelligibility, EEG, objective measure, hearing loss, hearing aid benefit, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hearing loss is one of the most prevalent impairments in the world. The World Health Organization estimates that as of 2020, around 466 million people worldwide are affected by disabling hearing loss, of which 34 million are children. Without appropriate diagnosis and treatment, hearing impairment can cause difficulties with communication, learning, social-emotional functioning, employment and quality of life. Early intervention is especially important for children, for whom unaddressed hearing loss has been proven to affect speech and language development, educational attainments, and social skills. Through early detection and interventions many of these impacts can be mitigated, highlighting the importance of accurate hearing diagnostics.
Evaluation of speech intelligibility is a fundamental component of hearing assessment and rehabilitation. The current gold standard in measuring speech intelligibility relies heavily on behavioural tests. While these tests are reliable and fast in healthy adults, it is challenging to assess speech intelligibility for patients who cannot communicate clearly, such as young children. For example, behavioral tests require active participation from the patient, such as raising their hand when a sound is heard, or repeating words and sentences.
Objective measures, for instance using electro-encephalography (EEG), could overcome the current challenges in hearing assessment and do not require active participation from the patient. For example, in Flanders, all newborns are screened with an objective test where a few sensors on the head detect brainwaves in response to sounds. However, objective tests only use simple sound stimuli, such as tones or clicks, which cannot be used to measure important high-level hearing outcomes, such as speech understanding. In other words, current objective tests are used to check if a person can hear a word, but they can't indicate if the person can understand the word.
An obvious missing link in audiological practice is a diagnostic test that can measure high-level hearing outcomes such as speech understanding in an objective way. For this reason, CORGEE was developed. CORGEE uses a novel method of "neural speech tracking" to objectively measure speech intelligibility using EEG. In the current study, the efficacy and the clinical validity of the CORGEE software will be evaluated in young children with a hearing impairment.
Detailed description
This study is set-up as a pre-market clinical investigation of a non-CE marked medical device. The main goal of the study is to measure the efficacy of the CORGEE software, a newly developed software application that will function as an added service in the auditory assessment and counselling by hearing care professionals for persons with (suspected) hearing-related problems.
We will evaluate the efficacy and the clinical validity of the CORGEE software by means of a within-subject cross-sectional study in infants, toddlers, kindergartners and primary school children. The study will be carried out in 90 children with (suspected) hearing impairment. Participants are recruited via four participating sites (one university hospital and three ambulatory revalidation centers) across a period of 12 months.
All participants will undergo an objective assessment of speech intelligibility based on electrophysiological responses to natural running speech, performed by their healthcare professional (HCP). Using the CORGEE device, neural tracking of the speech envelope will be investigated with and without hearing aids at different levels of speech intelligibility. With this clinical study, we aim to demonstrate an objective hearing aid benefit when listening to natural speech using EEG. Moreover, we aim to compare the objective results with behavioural measures of speech intelligibility obtained with standard-of-care assessments (speech audiometry). Additionally, by means of questionnaires we aim to determine the HCP's evaluation of the level of tolerance of the assessment for children, as well as the HCP's user experience and satisfaction with the CORGEE software. Finally, we will assess the usability of the CORGEE software as a counselling tool for persons with (suspected) hearing-related problems and their caregivers.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infants & toddlers | – | Other: Electrophysiological experimentChildren between 0 and 2,5 years of age |
| Kindergartners | – | Other: Electrophysiological experiment, Behavioral: Speech audiometryChildren between 2,5 and 6 years of age |
| Primary school children | – | Other: Electrophysiological experiment, Behavioral: Speech audiometryChildren between 6 and 12 years of age |
Who may qualify
- Ages
- 0 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with a bilateral hearing impairment in Flanders
Key inclusion criteria (21 listed)
- Subcategory 1 (Infants \& toddlers)
- Subcategory 2 (Kindergartners)
- Subcategory 3 (Primary school children)
Key exclusion criteria (3 listed)
- no exposure to Dutch
- known brain injuries
- acute illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrophysiological experimentAlso: Use of the CORGEE softwareNeural envelope tracking to conversational speech at different intensities | Other | Infants & toddlers, Kindergartners, Primary school children |
| Speech audiometrySpeech perception assessment at different intensities | Behavioural | Kindergartners, Primary school children |
Primary outcome
Neural speech tracking
Time frame: Baseline
Neural envelope tracking to conversational speech at different intensities. Here, neural envelope tracking represents the correlation between the original envelope (i.e. the envelope of the presented speech signal) and the reconstructed envelope (i.e., the envelope as calculated from the EEG)
1 secondary outcome
Speech intelligibility
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
Related trials for Hearing Disorders in Children
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
Not yet recruiting
Artificial Grammar Learning in Children Who Are Deaf or Hard-of-Hearing: Stimulus Length Effect
Hearing Impaired Children
RecruitingPhase 3
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Pediatric Migraine
RecruitingPhase 3
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Acute Treatment of Migraine
Recruiting
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Unilateral Hearing Loss, Asymmetric Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Disorders in Children and Hearing Loss, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural speech tracking (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.