Physiological, Behavioural and Subjective Measures of Listening Effort
2019年7月11日 更新者：Sonova AG
Effect of Noise Reduction Algorithms on Physiological, Behavioural and Subjective Measures of Listening Effort
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).
研究概览
研究类型
介入性
注册 (实际的)
17
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Stäfa、瑞士、8712
- Sonova AG
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 99年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Hearing Aid without NR enabled.
Hearing Aid without Noise Reduction (NR) enabled serves as reference condition.
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每个参与者都将配备降噪功能。
禁用意味着没有从语音信号中去除噪声的声音处理算法处于活动状态。
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实验性的：Hearing Aid with NR(1)
Hearing Aid with Noise Reduction I (NR) enabled.
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每个参与者都将在同一个助听器上安装降噪程序。
降噪算法的原理是去除语音信号中的噪声，以提高语音的清晰度和舒适度。
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实验性的：Hearing Aid with NR(2)
Hearing Aid with Noise Reduction II (NR) enabled.
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每个参与者都将在同一个助听器上安装第二个降噪程序。
此 NR 算法的参数化不同于 NR(1) 中的参数化。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Heart rate variability data
大体时间：6 weeks
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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.
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6 weeks
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Skin conductance data
大体时间：6 weeks
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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].
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6 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hemoencephalography data
大体时间：6 weeks
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Hemoencephalography 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.
Hemoencephalography will be analysed simply as the ratio of the blue and red light [%] during auditory task performance.
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6 weeks
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Dual-task performance test 1
大体时间：6 weeks
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Performance on the secondary tracking task will be analysed in order to observe whether there is a dual-task cost associated with performing both tasks simultaneously.
Typically the level of degradation on the secondary task is thought to reflect an increased listening effort (provided that the primary task performance remains stable).
Accordingly, success on the primary task will also be monitored and used in analyses (speech intelligibility in [%] correct).
For the Secondary task performance the reaction time [ms] will be analysed.
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6 weeks
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Dual-task performance test 2
大体时间：6 weeks
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Performance on the secondary tracking task will be analysed in order to observe whether there is a dual-task cost associated with performing both tasks simultaneously.
Typically the level of degradation on the secondary task is thought to reflect an increased listening effort (provided that the primary task performance remains stable).
Accordingly, success on the primary task will also be monitored and used in analyses (comprehension questions [numbers] correct after listening to radio excerpts).
For the Secondary task performance the reaction time [ms] will be analysed.
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6 weeks
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Subjective Listening Effort rating
大体时间：6 weeks
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Subjective Listening Effort will also be assessed through self-reported individual listening effort on a 14 point scale from "only noise" to "no effort" after each auditory task.
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6 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Juliane Raether、Sonova AG
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年10月8日
初级完成 (实际的)
2019年3月29日
研究完成 (实际的)
2019年4月30日
研究注册日期
首次提交
2018年11月30日
首先提交符合 QC 标准的
2018年11月30日
首次发布 (实际的)
2018年12月3日
研究记录更新
最后更新发布 (实际的)
2019年7月12日
上次提交的符合 QC 标准的更新
2019年7月11日
最后验证
2019年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.