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Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement

Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05985473
Acronym
REFINED
Enrollment
40
Registered
2023-08-14
Start date
2024-03-06
Completion date
2026-09-15
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deafness Neurosensory

Keywords

Spectrum of auditory neuropathy, speech enhancement, intelligibility, denoising methods, hearing loss

Brief summary

Individuals with Auditory Neuropathy Spectrum Disorders (ANSD) represent 1-10% of adults with hearing loss. These individuals have little or no benefit from current hearing aids because ANSD is a continuum of hearing impairments due to synaptic or neural dysfunction in the peripheral and central parts of the auditory pathways, which impairs temporal information processing without necessarily affecting auditory sensitivity. There is a need to find ad-hoc denoising methods, based on the expert knowledge of audiologists, to improve the noise comprehension performance of these patients. Implemented denoising methods, based on artificial intelligence, will also greatly benefit more standard hearing loss cases.

Detailed description

Longitudinal study consisting of multiple visits with multiple examinations over a total duration of approximately 3 years per ANSD participant and 1 year per normal hearing participant. * normal hearing participant : year 1 : Inclusion visit, Phenotyping visit (Audiological tests), Follow-up Visit 1 (Noise Comprehension Tests) * ANSD participant : year 1 : Inclusion visit, Phenotyping visit (Audiological tests), Follow-up Visit 1 (Noise Comprehension Tests) year 2 : Follow-up Visit 2 (Noise Comprehension Tests) year 3 : Follow-up Visit 3 (Noise Comprehension Tests)

Interventions

OTHERaudiological measurements

audiological measurements

OTHERObjective and subjective audiological measurements

Objective and subjective audiological measurements

OTHEREvaluation of the denoising methods REFINED

Evaluation of the denoising methods REFINED

Sponsors

Institut Pasteur
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

For all participants: * Age greater than or equal to 18 years, * French mother tongue, * Have an average tonal hearing loss (calculated according to the BIAP method) \< 30 dB HL, on headphones, for each ear, * Be professionally active, not be pre-retired and not be unemployed * Be affiliated with a social security plan, For participants with TSNA: \- Have degraded comprehension in noise (threshold of Intelligibility in Noise \> 3 dB compared to the norm). For controls: \- Have normal comprehension in noise (Intelligibility in Noise threshold ≤ 3 dB from the norm).

Exclusion criteria

For all participants: * Have a conductive or mixed hearing loss, which is when the hearing loss affects both the outer and/or middle ear and the inner ear. * Have an asymmetric hearing loss, i.e. a difference in average hearing loss between the left and right ear greater than 30 dB, * Have sequelae of ear infections and/or a history of ENT disease that permanently affects hearing (vestibular schwannoma, Meniere's disease, sudden or fluctuating deafness, congenital hypoacusis) * Being under guardianship, * Being deprived of liberty by judicial or administrative decision, or being subject to legal protection.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of percentage of words correctly repeated by participants (ANSD and controls)3 yearsEvaluate intelligibility, i.e. the percentage of words correctly repeated, for different speech and noise conditions. Tests will be repeated with and without application of speech enhancement methods to the sound.

Secondary

MeasureTime frameDescription
Auditory Brain Response (ABRs)3 yearsElectrical activity of auditoral pathways, from the auditory nerve to the brain, in response to sound stimuli.
Percentage of words correctly repeated by participants with different angles of separation of speech and noises sources3 yearsEvaluate intelligibility and performance of source localisation for different angles of separation of speech and noises sources
Percentage of phonemes correctly repeated by participants (Verbo-Frequential Audiometry in the presence of calibrated noise: the DODELE AVfB test)3 yearsEvaluate speech perception in noise with phonemes as testing speech
Percentage of words correctly repeated by participants at different sound level of noise3 yearsAssess intelligibility in noise. Vocal tests will be repeated with and without tactile cues.
Myogenic vestibular evoked potentials (cervical VEMP or c-VEMP).3 yearsc-VEMP assesses the vestibular function through saccular and inferior vestibular nerve function performances. The collected parameters of c-VEMP testing include c-VEMP threshold, the latencies of the initial positivity (p1) and negativity (n1), and the p1-n1 inter-amplitude. We will collect these parameters and assess differences in controls vs. ANSDs.
Subjective evaluation of listening comfort using a visual analog scale3 yearsThis self-assessment involves placing a cursor on a scale ranging from very uncomfortable to very comfortable using a scale ranging from 0 to 10.
Subjective evaluation of listening efficiency using a visual analog scale3 yearsThis self-assessment involves placing a cursor on a scale ranging from very inefficient to very efficient using a scale ranging from 0 to 10.

Countries

France

Contacts

Primary ContactMarta Campi, PhD
marta.campi@pasteur.fr++33 (0) 1 76 53 51 12
Backup ContactPaul Avan, MD
paul.avan@uca.fr+33 (0)1 76 53 50 94

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026