Status:
UNKNOWN
Technical Evaluation of Earswitch Phase B
Lead Sponsor:
University of Bath
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Earswitch Ltd.
Conditions:
Motor Neuron Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 s...
Detailed Description
Following recruitment and screening there are a number of different stages for the trial: 1. Initial face-to-face appointment (Clinical groups 2,3, and 4) 2. At-home setup (Clinical group 1) 3. At-ho...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06090448
Start Date
April 1 2024
End Date
April 1 2025
Last Update
December 14 2023
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