Tolerability of Wear of Electrode PadsCEPATNCT04012515
CAVA: Electrode Pad Appraisal Trial
A study testing Electrode Pads in people with Tolerability of Wear of Electrode Pads, run by Julie Dawson at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tolerability of Wear of Electrode Pads
- What is being tested?
- Electrode Pads
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Apr 2019to 5 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, NR7 7UY
About this study
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.
Read the 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
- Being tested
- Electrode Pads
- Keywords
- ECG Electrodes, ambulatory monitoring, dermatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrode PadsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CAVA Electrode Pad Appraisal Trial Arm | Experimental | All trial participants are within this arm. All participants will wear the same selection of electrode pads and follow the same replacement schedules. Receives: Device: Electrode Pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum duration of comfortable wear of electrode pad
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start8 Apr 2019
- Primary completion7 Feb 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tolerability of Wear of Electrode PadsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Dawson
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia, Medical Research Council
- Responsible party
- Sponsor-investigator, Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust
- Investigators
- John Phillips, Principal investigator, Consultant ENT Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012515
- Sponsor's protocol ID
- 261103 (25-02-19)
- Acronym
- CEPAT
- Status last verified
- Oct 2020
- First submitted
- 5 Apr 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Electrode Pad Appraisal Trial
- ClinicalTrials.gov ID
- NCT04012515
- Acronym / sponsor ID
- CEPAT / 261103 (25-02-19)
- Conditions
- Tolerability of Wear of Electrode Pads
- Keywords
- ECG Electrodes, ambulatory monitoring, dermatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Julie DawsonUniversity, hospital or other
- Collaborators
- University of East Anglia, Medical Research Council
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAVA Electrode Pad Appraisal Trial Arm | Experimental | Device: Electrode PadsAll trial participants are within this arm. All participants will wear the same selection of electrode pads and follow the same replacement schedules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrode PadsParticipants 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. | Device | CAVA Electrode Pad Appraisal Trial Arm |
Primary outcome
The maximum duration of comfortable wear of electrode pad
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Phillips principal investigator
Consultant ENT Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrode Pads in people with Tolerability of Wear of Electrode Pads, run by Julie Dawson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum duration of comfortable wear of electrode pad (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020; AzTrials last refreshed its copy on 30 Oct 2026.