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Completed
NCT04583826
sCAVA - Sleep Assessment Using the CAVA Device
Conditions: Sleep
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 9
Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Location: Norfolk and Norwich University Hospitals NHS Foundation Trust Norwich Norfolk
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT04583826). StuddyBuddy aggregates publicly available trial information.