Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Healthy Vol… (NCT03661762) | Clinical Trial Compass
CompletedNot Applicable
Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Healthy Volunteer Trial
United Kingdom18 participantsStarted 2018-08-23
Plain-language summary
Clinical investigation of a medical device (CAVA) for recording eye movements. Healthy volunteers will wear the device for 23 hours a day, for 30 days. On 8 separate days of the trial they will induce optokinetic nystagmus (a normal reflex in response to full-field motion) by watching a short video of less than 1 minute in duration. The data will be analysed offline by a scientist, who will attempt to identify the dates that the nystagmus was induced.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 and over
* Able to commit to 30 days of continuous wear of the trial device as per the study plan
* Own a telephone
Exclusion Criteria:
* Potential participants who have a history of dermatological disease or damage around the forehead
* Potential participants who have an allergy to plasters and/or medical adhesives
* History of dizziness, vertigo, balance disorders, or syncope
* History of hypertension or cardiac problems (uncontrolled, acute or de-compensated phase)
* History of ear disease, or previous ear surgery
* History of psychotic/neurotic disorders or epilepsy
* History of eye disease, or previous eye surgery
* Unable to follow the testing protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity and Specificity of a Computer Algorithm to Detect Artificially Induced Nystagmus