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临床试验/NCT06049199
NCT06049199Enrolling By Invitation不适用

Assess the Effect of Speech Enhancer on Listening Effort With EEG

Sonova AG2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
Sonova AG
入组人数
27
试验地点
2
主要终点
EEG alpha power measured during Listening Effort Task (LET)

研究概览

简要总结

In previous studies, Speech Enhancer has been shown to improve Listening Effort using a subjective method. To overcome the weakness of subjective testing, this study uses an objective measurement that has shown convincing results in previous studies addressing Listening Effort.

详细描述

The Speech Enhancer (SE) provides better speech intelligibility for soft speech while maintaining the same sound quality for loud input level.

Better speech intelligibility may also result in less listening effort in some circumstances. So there was the hope that the SE provides better speech intelligibility and less listening effort for situation with soft speech.

The SE has already been intensely and successfully investigated in early studies.

The cognitive performance on a neurophiosiological level has already been successfully investigated in a previous studies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Experienced (minimum use duration 6 months)
  • Adult (minimum age: 18 years) hearing aid users,
  • Symmetrical hearing loss (difference between ears <= 10 dB for 1kHz-6kHz),
  • Sensorineural hearing loss,
  • Air Conduction - bone conduction gap <= 10 dB,
  • Written and spoken German,
  • Ability to understand instruction,
  • Ability to describe listening experiences,
  • Ability to attend to the appointments,
  • Healthy outer ear (without previous surgical proce-dures),
  • Hearing loss within the fitting ranges of the investiga-tional product,
  • Informed consent as documented by signature.

排除标准

  • Clinical contraindications deformity of the ear (closed ear canal or absence of pinna),
  • Known hypersensitivity or allergy,
  • Not willing to wear the hearing aid,
  • Fluctuating hearing that could influence the results,
  • Limited mobility and not in the position to attend all appointments,
  • Inability to produce a reliable hearing test result,
  • Massively limited dexterity,
  • Known psychological problems,
  • Known central hearing disorders.

结局指标

主要结局

EEG alpha power measured during Listening Effort Task (LET)

时间窗: 10 weeks

During the LET experiment EEG data will be recorded while participants perform the Adaptive CAtegorical Listening Effort (ACALES). Participants will be equipped with an EEG cap. A continuous EEG will be recorded while participants are performing the LET. Based on the EEG data the alpha power will be analysed offline afterwards.

次要结局

  • Working memory measured with Listening Span Task (LST)(10 weeks)
  • EEG alpha power measured during Listening Span Task (LST)(10 weeks)
  • Listening effort (ACALES) measured during Listening Effort Task (LET)(10 weeks)

研究者

发起方
Sonova AG
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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