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

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.

Study Overview

• Status: Recruiting
• Conditions: Deafness Neurosensory
• Intervention / Treatment: Other: audiological measurements; Other: Objective and subjective audiological measurements; Other: Evaluation of the denoising methods REFINED

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul Avan, MD; Phone Number: +33 (0)1 76 53 50 94; Email: paul.avan@uca.fr
• Study Contact Backup: Name: Marta Campi, PhD; Phone Number: ++33 (0) 1 76 53 51 12; Email: marta.campi@pasteur.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • CEntre de Recherche et d'Innovation en Audiologie Humaine
    • Contact: Paul Avan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Auditory Brain Response (ABRs)	Electrical activity of auditoral pathways, from the auditory nerve to the brain, in response to sound stimuli.	3 years
Percentage of words correctly repeated by participants with different angles of separation of speech and noises sources	Evaluate intelligibility and performance of source localisation for 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)	Evaluate speech perception in noise with phonemes as testing speech	3 years
Percentage of words correctly repeated by participants at different sound level of noise	Assess intelligibility in noise. Vocal tests will be repeated with and without tactile cues.	3 years
Myogenic vestibular evoked potentials (cervical VEMP or c-VEMP).	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.	3 years
Subjective evaluation of listening comfort using a visual analog scale	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.	3 years
Subjective evaluation of listening efficiency using a visual analog scale	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.	3 years

Collaborators and Investigators

• Sponsor: Institut Pasteur
• Investigators: Principal Investigator: Paul Avan, MD, CEntre de Recherche et d'Innovation en Audiologie Humain

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: hearing loss; intelligibility; Spectrum of auditory neuropathy; speech enhancement; denoising methods
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: 2022-016; 2023-A00140-45 (Other Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No