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

NCT05985473 | Recruiting

• 2 other identifiers: 2022-0162023-A00140-45
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Deafness Neurosensory

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Comparison of percentage of words correctly repeated by participants (ANSD and controls)

  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.

  3 years

Secondary Outcomes (7)

• Auditory Brain Response (ABRs)

  3 years

• Percentage of words correctly repeated by participants with different angles of separation of speech and noises sources

  3 years

• Percentage of phonemes correctly repeated by participants (Verbo-Frequential Audiometry in the presence of calibrated noise: the DODELE AVfB test)

  3 years

• Percentage of words correctly repeated by participants at different sound level of noise

  3 years

• Myogenic vestibular evoked potentials (cervical VEMP or c-VEMP).

  3 years

Study Arms (1)

Professionally active adults with a moderate hearing loss

OTHER

Other: audiological measurements; Other: Objective and subjective audiological measurements; Other: Evaluation of the denoising methods REFINED

Interventions

audiological measurements OTHER

audiological measurements

Professionally active adults with a moderate hearing loss

Objective and subjective audiological measurements OTHER

Objective and subjective audiological measurements

Professionally active adults with a moderate hearing loss

Evaluation of the denoising methods REFINED OTHER

Evaluation of the denoising methods REFINED

Professionally active adults with a moderate hearing loss

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (1)

CEntre de Recherche et d'Innovation en Audiologie Humaine

Paris, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Paul Avan, MD

  CEntre de Recherche et d'Innovation en Audiologie Humain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Campi, PhD

CONTACT

++33 (0) 1 76 53 51 12; marta.campi@pasteur.fr

Paul Avan, MD

CONTACT

+33 (0)1 76 53 50 94; paul.avan@uca.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: August 14, 2023
• Study Start: March 6, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-02

Locations

FR (1)