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Recruiting NCT05985473

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

No phase Interventional Deafness Neurosensory

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: audiological measurements, Objective and subjective audiological measurements, Evaluation of the denoising methods REFINED.
Who it may be relevant to
Registry conditions: Deafness Neurosensory. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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)

Interventions

  • 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

Primary outcome measures

  • Comparison of percentage of words correctly repeated by participants (ANSD and controls) [Time frame: 3 years]
Secondary outcome measures (7)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • CEntre de Recherche et d'Innovation en Audiologie Humaine — Paris

Identifiers

NCT: NCT05985473 · 2022-016 · 2023-A00140-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗