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 range18 Years

SexALL

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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

What they're measuring

Sensitivity and Specificity of a Computer Algorithm to Detect Artificially Induced Nystagmus

Timeframe: 30 days

Trial details

NCT IDNCT03661762

SponsorJulie Dawson

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-12-12

Results submitted2019-10-25

View on ClinicalTrials.gov More Optokinetic Nystagmus trials