Technical Evaluation and Usability Analysis of a Novel Ear-worn Assistive Device - Phase B
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- To determine whether the EarSwitch system can be used for interaction by detecting in-ear movements (IEMs), and whether this differs with motor neurological disability and to assess its change over 4 weeks, in participants from three clinical groups.
研究概览
简要总结
The Earswitch is a demonstrated proof-of-concept that detects the voluntary contraction of a small muscle in the ear, called the tensor tympani (TT) muscle, which can be effectively used as an input switch. The voluntary activation of the TT makes the eardrum move, and such movement can be detected using a small camera inserted into the ear canal. A previously funded NIHR 'i4i Connect' research project showed how the Earswitch may be advantageous to populations with severe neuro-disabilities, where other communication methods are limited.
This project aims to realise the EarSwitch's potential as an assistive communication device and provide supporting evidence towards regulatory approval of the medical device.
The robustness and usability of the device will be tested on participants with mild-to-moderate neuro-disabilities and healthy participants. This complements data collected from assistive technology users following the same protocol but will provide additional data to train and understand the underlying detection algorithms for the Earswitch.
The ease of which an assistive technology device can be installed and calibrated independently (without guidance from the researcher) so that it is ready to use is also an important consideration for its potential adoption. Participants will have the opportunity to interactively use the Earswitch daily at home, over a prolonged period of 4 weeks. Interviews and questionnaires will be used to gather information on usability and comfort of the device, whilst data from the interactive tasks will provide feedback of engagement and performance.
Overall, this will provide crucial insights into how viable the Earswitch is as an assistive technology device and how accurately and reliably the current detection algorithm can detect contraction of the TT muscle. This data will be analysed to inform the final design of the Earswitch ready for commercial production.
详细描述
Following recruitment and screening there are a number of different stages for the trial:
-
Initial face-to-face appointment (Clinical groups 2,3, and 4)
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At-home setup (Clinical group 1)
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At-home testing (Clinical groups 1, 2, 3, and 4)
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Final face-to-face appointment (Clinical groups 2, 3, and 4)
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Initial Face-to-Face Appointment (Clinical groups 2, 3, and 4)
Participants will book an in-person appointment with PHU at Queen Alexandra Hospital.
The initial face-to-face appointment will involve six main parts:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
No masking will take place.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To determine whether the EarSwitch system can be used for interaction by detecting in-ear movements (IEMs), and whether this differs with motor neurological disability and to assess its change over 4 weeks, in participants from three clinical groups.
时间窗: 4 weeks
The primary outcome is the success rate of how well individuals completed the interactive click distribution analysis (ICDA) tasks after the four-week period which indicates how well they can interact using the EarSwitch device. Comparisons will be made within each clinical group between baseline (start of week 1), intermediate (end of weeks 1, 2 and 3), and end-of-trial (end of week 4) to see whether repeated use increase the success rate of interacting with the EarSwitch. Comparisons will be made across the clinical groups to see if there is any difference in the success when using the EarSwitch device.
次要结局
- To determine the acceptability of the EarSwitch as assessed quantitively using a 7-point Likert item scale questionnaire.(4 weeks)
- To determine the usability of the EarSwitch device as assessed by qualitative questionnaires.(4 weeks)
- How robust is the Earswitch technology in detecting voluntary eardrum movements? This will be measured by the F-score.(4 weeks)
- How robust is the Earswitch technology in detecting voluntary eardrum movements? This will be measured by the receiver operating characteristics (ROC) curve.(4 weeks)
- How robust is the Earswitch technology in detecting voluntary eardrum movements? This will be measured by the Area Under the ROC curve (AUC).(4 weeks)
- To determine the usability of the EarSwitch device as assessed by the system Usability Scale (SUS).(4 weeks)
- How robust is the Earswitch technology in detecting voluntary eardrum movements? This will be measured by the Matthews correlation coefficient (MCC).(4 weeks)
- To determine feasibility for the EarSwitch to be incorporated into routine clinical care, as assessed by number of participant incidents across the 4 week period.(4 weeks)
- To explore the frequency participants use the EarSwitch during a 4 week period.(4 weeks)
- To determine how physically comfortable the EarSwitch device is, as assessed by quantitative measures based on subjective questionnaires measuring the comfort and fit of the device.(4 weeks)
- To determine feasibility for the EarSwitch to be incorporated into routine clinical care, as assessed by quantitative questionnaires.(4 weeks)
- Determine whether the ability to voluntarily contract the tensor tympani i.e., ear rumble in isolation is trainable(4 weeks)
- Determine how well participants can perform in-ear movements (IEMs) due to contraction of the TT.(4 weeks)
- Assess optimum design and fit of the EarSwitch in-ear device at baseline and end of week 4 visits in Clinical Groups 2, 3 and 4(4 weeks)
研究者
Dario Cazzola
Principal Investigator
University of Bath