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临床试验/NCT07028658
NCT07028658招募中不适用

Efficacité de la rééducation Orthophonique de la Lecture Labiale Des Patients appareillés Auditifs : étude SCED

Institut Pasteur1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2025年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
8
试验地点
1
主要终点
Repetition score, in words (with and without labial doppelganger) of Lafon's cochlear lists presented on video support in visual-only modality

研究概览

简要总结

This study aims to investigate whether lip reading rehabilitation improves viseme recognition in individuals with hearing impairments who use hearing aids.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • •Patient aged 18 or older
  • •Affiliated with a social security system
  • •Moderate to severe bilateral post-lingual hearing loss, fitted with hearing aids for more than 6 months
  • •Wearing hearing aids for a minimum of 8 hours/day on average over the past month
  • •Intelligibility in quiet > 80% correct responses at 60 dB (Lafon cochlear list)
  • •Difficulty in noisy environments rated > 6 on a 0-10 EVA scale
  • •French language comprehension level of at least B1 CEFR (Common European Framework of Reference for Languages)
  • •Willing to participate in speech therapy rehabilitation at a rate of 2 sessions per week

排除标准

  • •Patient who has already undergone speech therapy rehabilitation as part of their hearing loss treatment
  • •Diagnosis of neurodegenerative disease or history of brain injury (traumatic brain injury, stroke, tumor, meningitis, etc.)
  • •Uncorrected vision or visual impairment affecting lip reading (e.g. AMD, glaucoma, unoperated cataract, etc.)
  • •Presence of severe tinnitus (score > 56) on the Tinnitus Handicap Inventory (THI) questionnaire
  • •Significant cognitive impairment (CODEX C or D) or Montreal Cognitive Assessment (MOCA) score < 23

结局指标

主要结局

Repetition score, in words (with and without labial doppelganger) of Lafon's cochlear lists presented on video support in visual-only modality

时间窗: 26 sessions (4,5 months)

Repetition score, in visemes (with and without labial doppelganger) of Lafon's cochlear lists presented on video support in visual-only modality

时间窗: 26 sessions (4,5 months)

次要结局

  • Repetition score of 10 non-words on recorded support with a Signal-to-Noise Ratio of 10(26 sessions (4,5 months))
  • Repetition score of sentences on video support in audiovisual modality(26 sessions (4,5 months))
  • Identification score of two sequences of musical notes(26 sessions (4,5 months))
  • Impact of speech therapy rehabilitation on quality of life(26 sessions (4,5 months))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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