Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
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
- 是
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
干预措施: Hearing Aid without frequency lowering enabled (Device)
Hearing Aid with frequency lowering enabled
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)
