Back to resultsReal-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement (REFINED)
Primary Purpose
Deafness Neurosensory
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
audiological measurements
Objective and subjective audiological measurements
Evaluation of the denoising methods REFINED
Sponsored by
About this trial
This is an interventional basic science trial for Deafness Neurosensory focused on measuring Spectrum of auditory neuropathy, speech enhancement, intelligibility, denoising methods, hearing loss
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.
Sites / Locations
- CEntre de Recherche et d'Innovation en Audiologie Humaine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Professionally active adults with a moderate hearing loss
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Auditory Brain Response (ABRs)
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
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)
Evaluate speech perception in noise with phonemes as testing speech
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05985473
Brief Title
Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement
Acronym
REFINED
Official Title
Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 20, 2023 (Anticipated)
Primary Completion Date
September 15, 2026 (Anticipated)
Study Completion Date
September 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness Neurosensory
Keywords
Spectrum of auditory neuropathy, speech enhancement, intelligibility, denoising methods, hearing loss
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Professionally active adults with a moderate hearing loss
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
audiological measurements
Intervention Description
audiological measurements
Intervention Type
Other
Intervention Name(s)
Objective and subjective audiological measurements
Intervention Description
Objective and subjective audiological measurements
Intervention Type
Other
Intervention Name(s)
Evaluation of the denoising methods REFINED
Intervention Description
Evaluation of the denoising methods REFINED
Primary Outcome Measure Information:
Title
Comparison of percentage of words correctly repeated by participants (ANSD and controls)
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Auditory Brain Response (ABRs)
Description
Electrical activity of auditoral pathways, from the auditory nerve to the brain, in response to sound stimuli.
Time Frame
3 years
Title
Percentage of words correctly repeated by participants with different angles of separation of speech and noises sources
Description
Evaluate intelligibility and performance of source localisation for different angles of separation of speech and noises sources
Time Frame
3 years
Title
Percentage of phonemes correctly repeated by participants (Verbo-Frequential Audiometry in the presence of calibrated noise: the DODELE AVfB test)
Description
Evaluate speech perception in noise with phonemes as testing speech
Time Frame
3 years
Title
Percentage of words correctly repeated by participants at different sound level of noise
Description
Assess intelligibility in noise. Vocal tests will be repeated with and without tactile cues.
Time Frame
3 years
Title
Myogenic vestibular evoked potentials (cervical VEMP or c-VEMP).
Description
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.
Time Frame
3 years
Title
Subjective evaluation of listening comfort using a visual analog scale
Description
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.
Time Frame
3 years
Title
Subjective evaluation of listening efficiency using a visual analog scale
Description
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.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Campi, PhD
Phone
++33 (0) 1 76 53 51 12
Email
marta.campi@pasteur.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Avan, MD
Phone
+33 (0)1 76 53 50 94
Email
paul.avan@uca.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Avan, MD
Organizational Affiliation
CEntre de Recherche et d'Innovation en Audiologie Humain
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEntre de Recherche et d'Innovation en Audiologie Humaine
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Avan, MD
12. IPD Sharing Statement
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Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement
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