CEPAT: CAVA: Electrode Pad Appraisal Trial

• Sponsor: Julie Dawson (Other)
• Overall Status: Completed
• CT.gov ID: NCT04012515
• Collaborator: University of East Anglia (Other), Medical Research Council (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 13.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tolerability of Wear of Electrode Pads	Device: Electrode Pads	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Electrode Pad Appraisal Trial
• Actual Study Start Date: Apr 8, 2019
• Actual Primary Completion Date: Feb 7, 2020
• Actual Study Completion Date: Jun 5, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Outcome Measures

Primary Outcome Measures

1. The maximum duration of comfortable wear of electrode pad [1 month]

   The maximum duration of comfortable wear will be calculated for each combination of electrode pad and wear regime, and the longest duration will determine the best electrode pad for use with the CAVA device.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norfolk & Norwich University Hospitals NHS Foundation Trust	Norwich		United Kingdom	NR7 7UY

Sponsors and Collaborators

• Julie Dawson
• University of East Anglia
• Medical Research Council

Investigators

• Principal Investigator: John Phillips, Consultant ENT Surgeon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Julie Dawson, Research Services Manager, Norfolk and Norwich University Hospitals NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04012515
• Other Study ID Numbers: 261103 (25-02-19)
• First Posted: Jul 9, 2019
• Last Update Posted: Oct 8, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Julie Dawson, Research Services Manager, Norfolk and Norwich University Hospitals NHS Foundation Trust: ECG Electrodes; ambulatory monitoring; dermatology

Study Results

No Results Posted as of Oct 8, 2020