Technical Evaluation and Usability Analysis of a Novel Ear-worn Assistive Device
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- How robust is the Earswitch technology in detecting voluntary eardrum movements? This will be measured by the F-score, Matthews correlation coefficient (MCC), the receiver operating characteristics (ROC) curve, and the Area Under the ROC curve (AUC).
研究概览
简要总结
The goal of this study is to test the Earswitch device in both participants with and without assistive technology (AT) needs. The main aim is to determine how robust the Earswitch is in detecting voluntary eardrum movements (known as ear rumbling) and see how well the Earswitch fits with other assistive technology. To do this, participants will be asked to wear the Earswitch device and voluntarily contract their TT to complete a series of tasks shown on screen and/or explained audibly. Participants will be asked to complete questionnaires to understand their opinions about the effectiveness, usability, and comfort of both their current device (if applicable) and the Earswitch. This feedback will be invaluable in developing the Earswitch.
详细描述
The overall aim of this study is to evaluate the robustness of the EarSwitch technology (hardware and software) in detecting voluntary eardrum movements in people with assistive needs. This is a key step to ensure a robust design informed by patients' needs.
A secondary aim is to gather information from assistive device users about how well they can perform voluntary eardrum movements, as this knowledge will be used to inform what types of interfaces are appropriate for the Earswitch.
Healthy participants will also be recruited as a separate cohort, to maximise the amount of data collected which can be used to validate and inform future designs. The methodology will be the same across both cohorts with the same equipment (Earswitch, second screen, and laptop) being used, however the healthy participants will not be able to answer all questions in PART 1. Healthy participants will be invited into a University lab to undertake the study, whereas participants with assistive technology needs will be given the option of a home visit. As the same equipment will be used, only the environment (i.e., home vs lab) will change which is not anticipate to affect the study data.
At the start of the study a signal will be agreed with the participant (and carer when required) so that the participant can inform their carer and/or the experimenter if they wish to stop the study for any reason. The proposed study will take place in a single session and includes four main parts:
PART 1 - Co-design Questionnaires. The specific aims for this part are to collect data on what assistive technologies people use and gain feedback on current switch technologies to better understand how the Earswitch can be integrated in conjunction with other switch technology. The participants will be asked questions to understand the type of assistive technology (hardware and software) they currently use. This will include their opinions about the effectiveness, usability, and comfort of their current device, measured using the previously validated QUEST2 questionnaire. This process should not take more than 15 minutes, and will be carried out by the researcher, with the support of a carer where necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Able to voluntarily contract the tensor tympani muscle
- •We will be recruiting participants who require assistive technology, as well as people who don't. For the former there will be the requirement that:
- •Individual requires the use of an assistive device in everyday life
排除标准
- •Those who do not have the capacity to understand the study and consent (e.g., severe learning disabilities).
- •Inability to communicate either directly to the researcher or through a carer or communication partner and therefore inability to provide consent.
结局指标
主要结局
How robust is the Earswitch technology in detecting voluntary eardrum movements? This will be measured by the F-score, Matthews correlation coefficient (MCC), the receiver operating characteristics (ROC) curve, and the Area Under the ROC curve (AUC).
时间窗: 6 months
The F-score represents the robustness of the Earswitch in detecting TT contraction and is the harmonic mean of the precision and recall of the binary classifier used to assess whether an ear rumble has taken place. The MCC measures the quality of binary classifications, calculated from the confusion matrix which includes true positives, true negatives, false positives and false negatives. A ROC curve shows the performance of the classification model at all classification thresholds, from which the AUC metric will be calculated providing an aggregate measure of performance across all classification thresholds. AUC ranges from 0-1, with greater values indicating more correct. This gives an overall metric of the model that is invariant to the classification-threshold and can be used to assess different classification models. However, for practical applications of the Earswitch one would want to minimise false positives and hence the individual F-scores and MCC will be calculated.
次要结局
- Q2: How accurately can people with assistive technology needs perform voluntary TT movements?(6 months)
- : Is there a difference in the accuracy of TT movements between those who require assistive technology and those who do?(6 months)
- How physically comfortable is the Earswitch?(6 months)
- How comfortable and easy is for people to perform voluntary eardrum movements with the EarSwitch?(6 months)
研究者
Dario Cazzola
Principal Investigator
University of Bath