An 'Off-the-shelf' Assistive Listening Device: Normal-hearing Children.
Tracking Information | |||
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First Submitted Date ICMJE | September 25, 2018 | ||
First Posted Date ICMJE | October 4, 2018 | ||
Last Update Posted Date | October 4, 2018 | ||
Actual Study Start Date ICMJE | October 25, 2018 | ||
Estimated Primary Completion Date | June 24, 2019 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures 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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Original Primary Outcome Measures ICMJE | Same as current | ||
Current Secondary Outcome Measures ICMJE |
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Descriptive Information | |||
Brief Title ICMJE | An 'Off-the-shelf' Assistive Listening Device: Normal-hearing Children. |
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Official Title ICMJE | Testing Speech Intelligibility Outcomes With a Commercial Bone-conduction Headset in Children With Normal Hearing. |
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Brief Summary | 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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Detailed Description | |||
Study Type ICMJE | Interventional | ||
Study Phase | N/A | ||
Study Design ICMJE | Allocation: Intervention Model: Single Group Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Supportive Care |
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Condition ICMJE | |||
Intervention ICMJE |
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Study Arms |
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Recruitment Information | |||
Recruitment Status ICMJE | Not yet recruiting | ||
Estimated Enrollment ICMJE |
24 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date | June 24, 2019 | ||
Estimated Primary Completion Date | June 24, 2019 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria 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. | ||
Sex/Gender |
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Ages | 6 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers | No | ||
Listed Location Countries ICMJE | United Kingdom | ||
Removed Location Countries | |||
Administrative Information | Has Data Monitoring Committee | ||
U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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IPD Sharing Statement |
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Responsible Party | , | ||
Study Sponsor ICMJE | Children's Hearing Evaluation and Amplification Resource, Ltd. | ||
Collaborators ICMJE | |||
Investigators ICMJE |
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PRS Account | |||
Verification Date | October 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |