sCAVA - Sleep Assessment Using the CAVA Device (NCT04583826) | Clinical Trial Compass
CompletedNot Applicable
sCAVA - Sleep Assessment Using the CAVA Device
United Kingdom9 participantsStarted 2020-04-02
Plain-language summary
Clinical investigation of a medical device (CAVA) for recording eye movements. Forty volunteers will sleep in a specially designed sleep lab for one or two nights, depending on whether they are enrolled onto phase 1 (two nights) or phase 2 (one night) of the study. Each volunteer will wear the CAVA device along with a Polysomnography (PSG) device, which is the gold standard for monitoring sleep. The twenty participants in phase 2 will simultaneously wear a commercially available consumer device for monitoring sleep. The eye movement data captured using CAVA will be processed by novel computer algorithms to classify the sleep stages in the data into Rapid Eye Movement (REM), non-REM and awake. The results will be compared with the ground-truth from the gold standard, and also compared to the results from the commercially available device. The aim of the study is to determine whether CAVA could be a viable and competitive home-monitoring device for analysing sleep.
Who can participate
Age range
19 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
* ≥ 18 years of age
* Conversational English and capacity to consent
* Availability to take part in the study
Exclusion criteria
* Potential participants who have a diagnosed sleep disorder, ongoing neurological or psychiatric disorders, or any potentially life-threatening conditions.
* Potential participants who have a history of dermatological disease, fragile skin, or damage around the forehead.
* Potential participants who have an allergy to plasters and/or medical adhesives (similarly to materials used in the device).
* Pregnant or nursing mothers.
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 the results
Timeframe: Study duration, approximately 6 months
Trial details
NCT IDNCT04583826
SponsorNorfolk and Norwich University Hospitals NHS Foundation Trust