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COMPLETED
NCT04583826
NA

sCAVA - Sleep Assessment Using the CAVA Device

Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2020-04-02

Completion Date

2024-11-05

Last Updated

2026-06-09

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

CAVA

CAVA is a medical device containing 5 face-mounted ECG electrodes which are used to record the movement of the eyes.

Locations (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, United Kingdom