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临床试验/NCT05985473
NCT05985473招募中不适用

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

Institut Pasteur1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Comparison of percentage of words correctly repeated by participants (ANSD and controls)

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

Professionally active adults with a moderate hearing loss

Other

干预措施: audiological measurements (Other)

Professionally active adults with a moderate hearing loss

Other

干预措施: Objective and subjective audiological measurements (Other)

Professionally active adults with a moderate hearing loss

Other

干预措施: Evaluation of the denoising methods REFINED (Other)

结局指标

主要结局

Comparison of percentage of words correctly repeated by participants (ANSD and controls)

时间窗: 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.

次要结局

  • Percentage of words correctly repeated by participants at different sound level of noise(3 years)
  • Subjective evaluation of listening comfort using a visual analog scale(3 years)
  • Auditory Brain Response (ABRs)(3 years)
  • Percentage of words correctly repeated by participants with different angles of separation of speech and noises sources(3 years)
  • Myogenic vestibular evoked potentials (cervical VEMP or c-VEMP).(3 years)
  • Percentage of phonemes correctly repeated by participants (Verbo-Frequential Audiometry in the presence of calibrated noise: the DODELE AVfB test)(3 years)
  • Subjective evaluation of listening efficiency using a visual analog scale(3 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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