Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402994
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-04-22
Brief Title:
Automated Measures of Speech Intelligibility Using Brain Wave Recordings
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Automated Measures of Speech Intelligibility Using Brain Wave Recordings
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORGEE
Brief 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 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 cant 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
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 cant 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 HCPs evaluation of the level of tolerance of the assessment for children as well as the HCPs 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
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 HCPs evaluation of the level of tolerance of the assessment for children as well as the HCPs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIV-23-08-043833 | OTHER | Eudamed | None |