Effect of Noise Reduction Algorithms on Physiological, Behavioural and Subjective Measures of Listening Effort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Heart rate variability data
研究概览
简要总结
Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) listening to short radio excerpts and answering subsequent comprehension questions. At the same time participants are required to perform a manual target-tracking task on a touch screen. During this study, continuous, non-invasive physiological measurements (heart rate, skin conductance and hemoencephalography) will be made from participants. Using this paradigm we will be assessing the effect of different hearing aid processing algorithms on listening effort. The study takes the form of a three factor (listening task x algorithm x signal-to-noise ratio), within-subjects design. Each participant performs each listening task (about 4min long each) with each algorithm (reference, noise reduction I, noise reduction II), at two signal-to-noise ratios (+4 decibel and 0 decibel) twice (test-retest).
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 NR enabled.
Hearing Aid without Noise Reduction (NR) enabled serves as reference condition.
干预措施: Hearing Aid without NR enabled (Device)
Hearing Aid with NR(1)
Hearing Aid with Noise Reduction I (NR) enabled.
干预措施: Hearing Aid with NR(1) (Device)
Hearing Aid with NR(2)
Hearing Aid with Noise Reduction II (NR) enabled.
干预措施: Hearing Aid with NR(2) (Device)
结局指标
主要结局
Heart rate variability data
时间窗: 6 weeks
Heart rate variability 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), in order to account for differences in baseline physiological activity. Heart rate variability will be analysed in both the time \[ms\] and frequency \[ms squared\] domains.
Skin conductance data
时间窗: 6 weeks
Skin conductance 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), in order to account for differences in baseline physiological activity. It is planned to analyse mean levels of skin conductance \[micro-Siemens\].
次要结局
- Dual-task performance test 1(6 weeks)
- Dual-task performance test 2(6 weeks)
- Subjective Listening Effort rating(6 weeks)
- Hemoencephalography data(6 weeks)