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

Sponsor

Institut Pasteur (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05985473

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Deafness Neurosensory	Other: audiological measurements Other: Objective and subjective audiological measurements Other: Evaluation of the denoising methods REFINED	N/A

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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Sep 15, 2026

Anticipated Study Completion Date :

Sep 15, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Professionally active adults with a moderate hearing loss	Other: audiological measurements audiological measurements Other: Objective and subjective audiological measurements Objective and subjective audiological measurements Other: Evaluation of the denoising methods REFINED Evaluation of the denoising methods REFINED

Arm

Intervention/Treatment

Other: Professionally active adults with a moderate hearing loss

Other: audiological measurements

audiological measurements

Other: Objective and subjective audiological measurements

Objective and subjective audiological measurements

Other: Evaluation of the denoising methods REFINED

Evaluation of the denoising methods REFINED

Outcome Measures

Primary Outcome Measures

Comparison of percentage of words correctly repeated by participants (ANSD and controls) [3 years]
Evaluate 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 Outcome Measures

Auditory Brain Response (ABRs) [3 years]
Electrical 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 sources [3 years]
Evaluate 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 years]
Evaluate speech perception in noise with phonemes as testing speech
Percentage of words correctly repeated by participants at different sound level of noise [3 years]
Assess intelligibility in noise. Vocal tests will be repeated with and without tactile cues.
Myogenic vestibular evoked potentials (cervical VEMP or c-VEMP). [3 years]
c-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 scale [3 years]
This 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 scale [3 years]
This self-assessment involves placing a cursor on a scale ranging from "very inefficient to very efficient" using a scale ranging from 0 to 10.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.