CAVA: Electrode Pad Appraisal Trial
CEPAT
Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Electrode Pad Appraisal Trial
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2019
CompletedStudy Start
First participant enrolled
April 8, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2020
CompletedOctober 8, 2020
October 1, 2020
10 months
April 5, 2019
October 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 month
Study Arms (1)
CAVA Electrode Pad Appraisal Trial Arm
EXPERIMENTALAll trial participants are within this arm. All participants will wear the same selection of electrode pads and follow the same replacement schedules.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Julie Dawsonlead
- University of East Angliacollaborator
- Medical Research Councilcollaborator
Study Sites (1)
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, NR7 7UY, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
John Phillips
Consultant ENT Surgeon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Services Manager
Study Record Dates
First Submitted
April 5, 2019
First Posted
July 9, 2019
Study Start
April 8, 2019
Primary Completion
February 7, 2020
Study Completion
June 5, 2020
Last Updated
October 8, 2020
Record last verified: 2020-10