Clinical trial NCT04012515: CAVA: Electrode Pad Appraisal Trial
Official title: Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Electrode Pad Appraisal Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tolerability of Wear of Electrode Pads
Keywords: ECG Electrodes
ambulatory monitoring
dermatology
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of East Anglia
name: Medical Research Council
First posted: 2019-07-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and over.
* Able to commit to 30 days of continuous wear of the electrode pads as per the study plan.
* Own a telephone.

Exclusion Criteria:

* Potential participants who have a history of dermatological disease, damage around the forehead, or fragile skin.
* Potential participants who have an allergy to plasters and/or medical adhesives.
* Potential participants who have taken part in a previous CAVA trial.
* Potential participants who are currently taking part in another trial.
* Unable to follow the testing protocol.

Primary outcomes:
measure: The maximum duration of comfortable wear of electrode pad
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospitals NHS Foundation Trust
Study officials:
affiliation: Consultant ENT Surgeon
name: John Phillips
role: PRINCIPAL_INVESTIGATOR
References: