Deafness NeurosensoryREFINEDNCT05985473
Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement
A study testing audiological measurements, Objective and subjective audiological measurements and Evaluation of the denoising methods REFINED in people with Deafness Neurosensory, run by Institut Pasteur at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deafness Neurosensory
- What is being tested?
- audiological measurements, Objective and subjective audiological measurements and Evaluation of the denoising methods REFINED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2024to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CEntre de Recherche et d'Innovation en Audiologie Humaine
Paris
Paul Avan, MD
About this study
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.
Read the 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
- Being tested
- audiological measurements, Objective and subjective audiological measurements, Evaluation of the denoising methods REFINED
- Keywords
- Spectrum of auditory neuropathy, speech enhancement, intelligibility, denoising methods, hearing loss
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
audiological measurementsOther
audiological measurements
Objective and subjective audiological measurementsOther
Objective and subjective audiological measurements
Evaluation of the denoising methods REFINEDOther
Evaluation of the denoising methods REFINED
| Study group | Role | What they receive |
|---|---|---|
| Professionally active adults with a moderate hearing loss | Other | Not described Receives: Other: audiological measurements; Other: Objective and subjective audiological measurements; Other: Evaluation of the denoising methods REFINED |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (7)
Auditory Brain Response (ABRs)
Electrical activity of auditoral pathways, from the auditory nerve to the brain, in response to sound stimuli.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start6 Mar 2024
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deafness NeurosensoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Avan, MD, Principal investigator, CEntre de Recherche et d'Innovation en Audiologie Humain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985473
- Sponsor's protocol ID
- 2022-016
- Other IDs
- 2023-A00140-45
- Acronym
- REFINED
- Status last verified
- Feb 2024
- First submitted
- 22 May 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement
- ClinicalTrials.gov ID
- NCT05985473
- Acronym / sponsor ID
- REFINED / 2022-016
- Conditions
- Deafness Neurosensory
- Keywords
- Spectrum of auditory neuropathy, speech enhancement, intelligibility, denoising methods, hearing loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| audiological measurementsaudiological measurements | Other | Professionally active adults with a moderate hearing loss |
| Objective and subjective audiological measurementsObjective and subjective audiological measurements | Other | Professionally active adults with a moderate hearing loss |
| Evaluation of the denoising methods REFINEDEvaluation of the denoising methods REFINED | Other | Professionally active adults with a moderate hearing loss |
Primary outcome
Comparison of percentage of words correctly repeated by participants (ANSD and controls)
Time frame: 3 years
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.
7 secondary outcomes
Auditory Brain Response (ABRs)
Time frame: 3 years
Percentage of words correctly repeated by participants with different angles of separation of speech and noises sources
Time frame: 3 years
Percentage of phonemes correctly repeated by participants (Verbo-Frequential Audiometry in the presence of calibrated noise: the DODELE AVfB test)
Time frame: 3 years
Percentage of words correctly repeated by participants at different sound level of noise
Time frame: 3 years
Myogenic vestibular evoked potentials (cervical VEMP or c-VEMP).
Time frame: 3 years
Subjective evaluation of listening comfort using a visual analog scale
Time frame: 3 years
Subjective evaluation of listening efficiency using a visual analog scale
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Related trials for Deafness Neurosensory
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
RecruitingPhase 2
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced
Not yet recruitingPhase 3
Autologous Circulating Extracellular Vesicles for Total-Type Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss (SSNHL)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Avan, MD principal investigator
CEntre de Recherche et d'Innovation en Audiologie Humain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing audiological measurements, Objective and subjective audiological measurements and Evaluation of the denoising methods REFINED in people with Deafness Neurosensory, run by Institut Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Campi, PhD (++33 (0) 1 76 53 51 12, marta.campi@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of percentage of words correctly repeated by participants (ANSD and controls) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.