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

NCT ID: NCT05985473

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-06
• Study Completion Date: 2026-09-15

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)

Conditions

Deafness Neurosensory

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Professionally active adults with a moderate hearing loss

Group Type: OTHER

audiological measurements

Intervention Type: OTHER

audiological measurements

Objective and subjective audiological measurements

Intervention Type: OTHER

Objective and subjective audiological measurements

Evaluation of the denoising methods REFINED

Intervention Type: OTHER

Evaluation of the denoising methods REFINED

Interventions

audiological measurements

audiological measurements

Intervention Type: OTHER

Objective and subjective audiological measurements

Objective and subjective audiological measurements

Intervention Type: OTHER

Evaluation of the denoising methods REFINED

Evaluation of the denoising methods REFINED

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Pasteur

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Avan, MD

Role: PRINCIPAL_INVESTIGATOR

CEntre de Recherche et d'Innovation en Audiologie Humain

Locations

CEntre de Recherche et d'Innovation en Audiologie Humaine

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marta Campi, PhD

Role: CONTACT

marta.campi@pasteur.fr

++33 (0) 1 76 53 51 12

Paul Avan, MD

Role: CONTACT

paul.avan@uca.fr

+33 (0)1 76 53 50 94

Facility Contacts

Paul Avan, MD

Role: primary

Other Identifiers

2023-A00140-45

Identifier Type: OTHER

Identifier Source: secondary_id

2022-016

Identifier Type: -

Identifier Source: org_study_id