Technical Evaluation of Earswitch Phase B
Technical Evaluation and Usability Analysis of a Novel Ear-worn Assistive Device - Phase B
2 other identifiers
interventional
150
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedDecember 14, 2023
December 1, 2023
1 year
September 4, 2023
December 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
4 weeks
Secondary Outcomes (23)
To explore the frequency participants use the EarSwitch during a 4 week period.
4 weeks
To explore the frequency participants use the EarSwitch during a 4 week period.
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 the system Usability Scale (SUS).
4 weeks
To determine the usability of the EarSwitch device as assessed by qualitative questionnaires.
4 weeks
- +18 more secondary outcomes
Study Arms (2)
University of Bath - Clinical group 1
OTHERParticipants 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.
Portsmouth Hospital Unit (PHU) - Clinical groups 2,3 & 4
OTHERThree 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.
Interventions
The Earswitch™ device consists of an earpiece made from silicon or similar bio-compatible material and incorporates a miniature camera. The earpiece sits within the ear canal and is not in direct contact with the eardrum and the camera is not in contact with the ear-canal. The camera detects voluntary movement from the tensor tympani muscle as presented at the eardrum and the Earswitch system translates this movement to an external virtual keypad or similar to allow the patient to communicate nonverbally.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bathlead
- National Institute for Health Research, United Kingdomcollaborator
- Earswitch Ltd.collaborator
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dario Cazzola, MEng,PhD
University of Bath
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- No masking will take place.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 4, 2023
First Posted
October 19, 2023
Study Start
April 1, 2024
Primary Completion
April 1, 2025
Study Completion
April 1, 2025
Last Updated
December 14, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share
Participant data will be automatically anonymised and therefore individual participant data will not be available to other researchers. Anonymised data will be transferred to Earswitch Ltd and analysed in the future by Earswitch Ltd for the development of more robust algorithms for detecting voluntary tensor tympani movement.