Clinical trial NCT05985473: Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement
Official title: Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deafness Neurosensory
Keywords: Spectrum of auditory neuropathy
speech enhancement
intelligibility
denoising methods
hearing loss
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of percentage of words correctly repeated by participants (ANSD and controls)
timeFrame: 3 years
Secondary outcomes:
measure: Auditory Brain Response (ABRs)
timeFrame: 3 years
measure: Percentage of words correctly repeated by participants with different angles of separation of speech and noises sources
timeFrame: 3 years
measure: Percentage of phonemes correctly repeated by participants (Verbo-Frequential Audiometry in the presence of calibrated noise: the DODELE AVfB test)
timeFrame: 3 years
measure: Percentage of words correctly repeated by participants at different sound level of noise
timeFrame: 3 years
measure: Myogenic vestibular evoked potentials (cervical VEMP or c-VEMP).
timeFrame: 3 years
measure: Subjective evaluation of listening comfort using a visual analog scale
timeFrame: 3 years
measure: Subjective evaluation of listening efficiency using a visual analog scale
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: CEntre de Recherche et d'Innovation en Audiologie Humaine
Study officials:
affiliation: CEntre de Recherche et d'Innovation en Audiologie Humain
name: Paul Avan, MD
role: PRINCIPAL_INVESTIGATOR
References: