CAVA: Electrode Pad Appraisal Trial

NCT ID: NCT04012515

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-08
• Study Completion Date: 2020-06-05

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.

Conditions

Tolerability of Wear of Electrode Pads

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

CAVA Electrode Pad Appraisal Trial Arm

All trial participants are within this arm. All participants will wear the same selection of electrode pads and follow the same replacement schedules.

Group Type: EXPERIMENTAL

Electrode Pads

Intervention Type: DEVICE

Participants wear six electrode pads in total; three different types of pad, worn in the same positions on both sides of the face. The pads on the left-hand side of the face are replaced daily, and those on the right-hand side are replaced every other day. The pads do not administer a medical treatment or perform any other active function. The purpose of the intervention is to determine which combination of pad and replacement regime maximises the tolerability of wear over a 30-day period.

Interventions

Electrode Pads

Participants wear six electrode pads in total; three different types of pad, worn in the same positions on both sides of the face. The pads on the left-hand side of the face are replaced daily, and those on the right-hand side are replaced every other day. The pads do not administer a medical treatment or perform any other active function. The purpose of the intervention is to determine which combination of pad and replacement regime maximises the tolerability of wear over a 30-day period.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of East Anglia

OTHER

Sponsor Role: collaborator

Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

Julie Dawson

OTHER

Sponsor Role: lead

Responsible Party

Julie Dawson

Research Services Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Phillips

Role: PRINCIPAL_INVESTIGATOR

Consultant ENT Surgeon

Locations

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, , United Kingdom

Countries

United Kingdom

Other Identifiers

261103 (25-02-19)

Identifier Type: -

Identifier Source: org_study_id