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CAVA: Electrode Pad Appraisal Trial (CEPAT)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tolerability of Wear of Electrode Pads | Device: Electrode Pads | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| 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 : | April 8, 2019 |
| Actual Primary Completion Date : | February 7, 2020 |
| Actual Study Completion Date : | June 5, 2020 |
| 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.
|
- 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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
| United Kingdom | |
| Norfolk & Norwich University Hospitals NHS Foundation Trust | |
| Norwich, United Kingdom, NR7 7UY | |
| Principal Investigator: | John Phillips | Consultant ENT Surgeon |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 5, 2019 | ||||
| First Posted Date ICMJE | July 9, 2019 | ||||
| Last Update Posted Date | October 8, 2020 | ||||
| Actual Study Start Date ICMJE | April 8, 2019 | ||||
| Actual Primary Completion Date | February 7, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | CAVA: Electrode Pad Appraisal Trial | ||||
| Official Title ICMJE | Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Electrode Pad Appraisal Trial | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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| Condition ICMJE | Tolerability of Wear of Electrode Pads | ||||
| Intervention ICMJE | 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.
|
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| Study Arms ICMJE | 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.
Intervention: Device: Electrode Pads
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
10 | ||||
| Original Estimated Enrollment ICMJE |
30 | ||||
| Actual Study Completion Date ICMJE | June 5, 2020 | ||||
| Actual Primary Completion Date | February 7, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04012515 | ||||
| Other Study ID Numbers ICMJE | 261103 (25-02-19) | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust | ||||
| Study Sponsor ICMJE | Julie Dawson | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Norfolk and Norwich University Hospitals NHS Foundation Trust | ||||
| Verification Date | October 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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