跳至主要内容
临床试验/NCT03992963
NCT03992963已完成不适用

Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application

Sonova AG2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Sonova AG
入组人数
8
试验地点
2
主要终点
Changes in event-related-pupil-dilations (ERPDs) data

研究概览

简要总结

Participants will take part in both a passive and active emotion recognition task: (1) passively listening to semantically-neutral sentences with emotional prosody, and (2) actively listening and subsequently categorizing emotional sentences and sounds. Participants are seated and instructed to stare at a fixation cross while the stimulus is played. During this study, non-invasive physiological measurements of pupil dilation will be recorded from the participants. Using this paradigm we will be assessing the effect of frequency lowering on emotion recognition. The study takes the form of a partly three factorial design (passive task x frequency lowering x acclimatization). Participants also perform a two factor design (active task x frequency lowering). Each participant performs two passive tests (20 minutes long each) with frequency lowering on and off, and a four week acclimatization period in-between. Participants perform one active listening task after the acclimatization period with frequency lowering on and off.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy outer ear (without previous surgical procedures)
  • Ability to fill in a questionnaire conscientiously
  • Informed Consent as documented by signature
  • Minimum 1 year hearing aid experience
  • Moderate-Severe (N3-N5) hearing loss or Normal Hearing

排除标准

  • Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
  • Limited mobility and not in the position to attend weekly appointments
  • Inability to produce a reliable hearing test result
  • Massively limited dexterity
  • Known psychological problems
  • Known central hearing disorders

研究组 & 干预措施

Hearing Aid without frequency lowering enabled

Active Comparator

干预措施: Hearing Aid without frequency lowering enabled (Device)

Hearing Aid with frequency lowering enabled

Experimental

干预措施: Hearing Aid with frequency lowering enabled (Device)

结局指标

主要结局

Changes in event-related-pupil-dilations (ERPDs) data

时间窗: 6 weeks

Pupil dilations will be recorded from the participant both before and during the performance of the auditory tasks. Analyses will be carried out relative to the baseline recording (made before the auditory tasks) and also the pre-trial baseline (measured one second prior to the onset of the stimulus), in order to account for differences in baseline physiological activity. It is planned to analyse event-related-pupil-dilations (ERPDs).

次要结局

  • self-perceived speech intelligibility rating(6 weeks)
  • behavioral emotion recognition categorical rating(6 weeks)
  • behavioral emotion recognition continuous rating(6 weeks)

研究者

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

研究点 (2)

Loading locations...

相似试验

Assessment of Novel Sound Changing Principles in... | 临床试验