Technical Evaluation and Usability Analysis of a Novel Ear-worn Assistive Device - Phase B
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Bath
- Enrollment
- 150
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Detailed Description
Following recruitment and screening there are a number of different stages for the trial:
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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:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Masking Description
No masking will take place.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •For all participants (Clinical groups 1, 2, 3, and 4) the following inclusion criteria will apply:
- •Aged 18 and older.
- •Able to give informed consent.
- •Access to an internet-connected device (e.g., laptop/PC/ tablet/smart phone) allowing connection to the Earswitch web based trial system.
- •Ability to operate, or have someone operate on their behalf, a web browser-based interface to respond to questionnaires.
- •Normal or corrected-to-normal vision.
- •Require the use of an assistive device (defined in Appendix....) in everyday life (Clinical group 1 only).
- •For clinical groups 1, 2, and 3 the following will also apply:
- •Able to voluntarily contract the tensor tympani muscle "in isolation" by self-identification, i.e., able to rumble the ear(s) "in isolation".
- •For clinical group 4 the following will also apply:
- •Unable to voluntarily contract their tensor tympani muscle in isolation by self-identification, i.e., unable to rumble the ear(s) "in isolation".
- •For clinical group 1 the following will also apply:
- •Individual's must require, or benefit from, the use of an assistive device in everyday life. For example, for use with communication, environmental control and/or mobility (excluding simple mechanical devices for example manual wheelchairs/walkers and frames) and excluding hearing-aids and visual aids.
- •For clinical group 2 the following will also apply:
- •Individuals must have a mild to moderate motor neurodisabilities and not require electronic assistive or communication (AAC) technology. The definition of mild to moderate motor-neurological disability is broad and will include participants with mild to moderate motor disabilities not requiring assistive technology (including MND/ Multiple Sclerosis/Parkinson's /Cerebral Palsy /Stroke / Post head injury /other rare degenerative diseases).
Exclusion Criteria
- •The following exclusion criteria will apply:
- •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.
- •Contraindication to use of EarSwitch including receiving treatment for an intercurrent ear infection or experiencing ear discharge or pain.
- •Unable to view eardrum despite removal of ear-wax by ear micro-suction.
Arms & Interventions
University of Bath - Clinical group 1
Participants will be Assistive Technology Users (clinical group 1) and the study will be conducted remotely at their homes. The device will be sent via post to their address.
Intervention: EarSwitch device (Device)
Portsmouth Hospital Unit (PHU) - Clinical groups 2,3 & 4
Three clinical groups will be recruited in Arm 2: 40 with mild-to-moderate motor neurodisabilities without communication assistive technology needs, 40 healthy participants and 20 who do not have the ability to ear rumble.
Participants will be required to attend two in-person visits at the Queen Alexandra Hospital at the beginning and end of the study. This is in addition to completing the home procedure using the Earswitch device at home.
Intervention: EarSwitch device (Device)
Outcomes
Primary Outcomes
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.
Time Frame: 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.
Secondary Outcomes
- 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)
- 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)
Investigators
Dario Cazzola
Principal Investigator
University of Bath