An 'Off-the-shelf' Assistive Listening Device: Normal-hearing Children.
追踪信息 | |||
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首次提交日期 ICMJE | September 25, 2018 | ||
首次发布日期e ICMJE | October 4, 2018 | ||
最后更新发布日期 | October 4, 2018 | ||
预计研究开始日期 ICMJE | October 25, 2018 | ||
预计主要完成日期 | June 24, 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Mc Cormick Toy Test[ Time Frame: Outcomes will be measured in a single session. Four runs are required. The total testing time is around 12 minutes. ] The main outcome measure will be an age-appropriate speech test. This test is called "McCormick Toy Test" and it consists in measuring the level needed for the child to identify 71% the words in a closed-set list. A minimum of three reversals is needed to determine the outcome. The outcome is the level of speech in dB (A). Lower levels indicate better performance. The test will be performed in quiet and in noise, with and without the headset. The statistical analysis will depend on the characteristics of the data. Because the data are discrete, performing Analysis of Variance (ANOVA) will not be possible. Comparisons of thresholds obtained in different conditions will be done using non-parametric tests. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | An 'Off-the-shelf' Assistive Listening Device: Normal-hearing Children. | ||
正式标题 ICMJE | Testing Speech Intelligibility Outcomes With a Commercial Bone-conduction Headset in Children With Normal Hearing. | ||
简要概况 | The cochlea, the sensory organ of hearing, is a structure of the temporal bone on the skull. In everyday life sounds are heard via air conduction. This means that vibrations in the air are conducted through our ear canals, via the eardrum and the middle-ear bones, to the cochlea. However, vibrations can be conducted to the cochlea via the bones of the head. Bone-conduction headsets have become popular for recreational use (for example cyclists and runners wear them to listen to music while exercising). When in a noisy environment, if a speech signal is delivered to a microphone connected via Bluetooth to the bone conduction headset, the person wearing the headset receives the speech signal as if the talker were closer to them. The ratio between the speech level and the noise level (SNR, signal-to-noise ratio) is increased, so that it is easier to understand the spoken message. A previous study carried out by the investigators has shown that this may help children with hearing loss due to otitis media with effusion ('glue ear'). The aim of the current study is to explore the potential of the headset to help children with auditory processing disorder (APD). Typically, children with APD have normal audiograms, but, in spite of this, they struggle to understand speech in a background noise. The headset can deliver the speech message to them. Currently, FM systems are used for children with APD in the classroom. These systems are effective, but their cost is high and provision may be limited. The feasibility of the use of the headset in a group of children with normal audiometric thresholds will be assessed. The study hypothesis is that using a bone-conduction headband improves speech recognition in noise and decreases listening effort even when air-conduction hearing thresholds are normal. Measures of speech recognition and listening effort will be done in quiet and in noise with and without the bone-conduction headset in order to measure the effect of using the headset on speech recognition when hearing thresholds are normal. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Supportive Care |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
24 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | June 24, 2019 | ||
预计主要完成日期 | June 24, 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: 1. Children aged 6 to 11 years old. 2. No developmental concerns 3. No concerns about hearing loss. 4. No concerns about language development. 5. English dominant language. Exclusion Criteria: 1. History, risk, or parent/carer/teacher concern of hearing loss. 2. Developmental concerns 3. Suspected language disability. 4. Non-English dominant language. | ||
性别 |
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年龄 | 最小年龄:6 Years ,最大年龄:11 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | United Kingdom | ||
管理信息 | 数据检测委员会 | ||
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | Children's Hearing Evaluation and Amplification Resource, Ltd. | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | |||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |