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NCT Number: NCT05985473

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEntre de Recherche et d'Innovation en Audiologie Humaine

Paris, France

Location status: Recruiting

Location contact

Paul Avan, MD

CONTACT

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

audiological measurements

Other

audiological measurements

Objective and subjective audiological measurements

Other

Objective and subjective audiological measurements

Evaluation of the denoising methods REFINED

Other

Evaluation of the denoising methods REFINED

Primary outcomes

  1. 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.

Secondary outcomes

  1. Auditory Brain Response (ABRs)

    Time frame: 3 years

    Electrical activity of auditoral pathways, from the auditory nerve to the brain, in response to sound stimuli.

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

    Time frame: 3 years

    Evaluate intelligibility and performance of source localisation for different angles of separation of speech and noises sources

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

    Time frame: 3 years

    Evaluate speech perception in noise with phonemes as testing speech

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

    Time frame: 3 years

    Assess intelligibility in noise. Vocal tests will be repeated with and without tactile cues.

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

    Time frame: 3 years

    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.

  6. Subjective evaluation of listening comfort using a visual analog scale

    Time frame: 3 years

    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.

  7. Subjective evaluation of listening efficiency using a visual analog scale

    Time frame: 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marta Campi, PhD

CONTACT

[email protected]

++33 (0) 1 76 53 51 12

Paul Avan, MD

CONTACT

[email protected]

+33 (0)1 76 53 50 94

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Registry information

Acronym: REFINED

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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