Automated Measures of Speech Intelligibility Using Brain Wave Recordings

NCT06402994 | Completed

• 2 other identifiers: S67892CIV-23-08-043833
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Hearing Disorders in Children; Hearing Loss

Keywords

speech intelligibility; EEG; objective measure; hearing loss; hearing aid benefit; children

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Speech intelligibility

  Baseline

Other Outcomes (1)

• Questionnaires

  Up to 12 months

Study Arms (3)

Infants & toddlers

Children between 0 and 2,5 years of age

Other: Electrophysiological experiment

Kindergartners

Children between 2,5 and 6 years of age

Other: Electrophysiological experiment; Behavioral: Speech audiometry

Primary school children

Children between 6 and 12 years of age

Other: Electrophysiological experiment; Behavioral: Speech audiometry

Interventions

Electrophysiological experiment OTHER

Neural envelope tracking to conversational speech at different intensities

Also known as: Use of the CORGEE software

Infants & toddlers; Kindergartners; Primary school children

Speech audiometry BEHAVIORAL

Speech perception assessment at different intensities

Kindergartners; Primary school children

Eligibility Criteria

• Age: 0 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with a bilateral hearing impairment in Flanders

You may qualify if:

• Subcategory 1 (Infants \& toddlers)
• ,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)
• ,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)
• years of age

You may not qualify if:

• no exposure to Dutch
• known brain injuries
• acute illness

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (4)

KOCA vzw

Antwerp, Antwerpen, 2018, Belgium

Location

CAR Sint-Lievenspoort

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

CAR Overleie

Kortrijk, West-Vlaanderen, 8500, Belgium

Location

MeSH Terms

Conditions

Hearing Loss; Speech Intelligibility

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Speech; Verbal Behavior; Communication; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 7, 2024
• Study Start: February 28, 2024
• Primary Completion: June 23, 2025
• Study Completion: June 23, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

BE (4)