Tolerability of Wear of Electrode Pads Clinical Trial
Official title:
Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Electrode Pad Appraisal Trial
This trial requires healthy volunteers to wear a selection of CE marked electrodes for up to 30 days. The results from this trial will determine which electrodes should be used with the CAVA device, which is a medical device for monitoring dizziness.
Dizziness is a common condition that is responsible for a significant degree of material
morbidity and burden on our health service. There are multiple causes of dizziness, and these
originate from pathologies affecting a large variety of different organ systems. Dizziness is
usually episodic and short-lived, so when a patient presents to their health care provider,
examination is often normal. As such, diagnosis is challenging and patients often experience
significant delay in receiving a diagnosis. We have developed a device for monitoring
dizziness and in 2018 we evaluated the device by undertaking a clinical trial involving
healthy volunteers. Following the promising results from the first trial, we will conduct a
second trial in 2019 on patients suffering from dizziness.
During the healthy volunteer trial, a minor issue was encountered relating to long-term daily
wear of the device's electrode pads. Specifically, nine participants reported varying degrees
of skin redness and inflammation beneath their electrode pads, mostly occurring after around
two weeks of wear. The issue was self-limiting and resolved after a few days of non-wear. The
team worked closely with a consultant dermatologist in order to monitor and manage this
adverse event.
Since the issue was identified, the team has consulted with a number of people with relevant
expertise in order to determine the causes of the issue and to find the most viable solution.
Based on these discussions, we propose that the causes of this issue were due to a
combination of wear duration, and/or repeated removal, and/or the specific type of electrode
pad used. To confidently identify the cause of this issue and to evaluate a number of
possible solutions, we intend to undertake a trial to evaluate the tolerability of
alternative electrode pads and different patterns of wear.
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