CORGEE
Sponsor study identifier
Secondary identifiers
OTHER · Eudamed
observational
100
1 country
4
Study Start
February 28, 2024
Actual (reported)Primary Completion
June 23, 2025
Actual (reported)Study Completion
June 23, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 23, 2025
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 28, 2024
Actual (reported)April 22, 2024
Actual (reported)May 7, 2024
Actual (reported)June 23, 2025
Actual (reported)June 23, 2025
Actual (reported)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)
Baseline
Speech intelligibility
Baseline
Questionnaires
Up to 12 months
Children between 0 and 2,5 years of age
Children between 2,5 and 6 years of age
Children between 6 and 12 years of age
Neural envelope tracking to conversational speech at different intensities
Children with a bilateral hearing impairment in Flanders
KOCA vzw
Antwerp, Antwerpen, 2018, Belgium
CAR Sint-Lievenspoort
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
CAR Overleie
Kortrijk, West-Vlaanderen, 8500, Belgium
100 participants (actual enrollment reported by the registry).
First Submitted
April 22, 2024
First Posted
May 7, 2024
Study Start
February 28, 2024
Actual (reported)Speech perception assessment at different intensities
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Primary Completion
June 23, 2025
Actual (reported)Study Completion
June 23, 2025
Actual (reported)Last Updated
September 9, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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