The CAVA Multicentre Dizziness Trial (NCT05984901) | Clinical Trial CompassUnknownNot Applicable
The CAVA Multicentre Dizziness Trial
United Kingdom255 participantsStarted 2022-04-01 Plain-language summary
The CAVA trial is a diagnostic accuracy multicentre device trial which aims to quantify the extent to which the CAVA system can differentiate three common inner-ear causes of dizziness: Ménière's disease, vestibular migraine and Benign Paroxysmal Positional Vertigo (BPPV).
The CAVA device is composed of two components: a set of bespoke single-use sensor arrays that adhere to the left and right side of the participant's face; and a small reusable module fitting over the ear that contains a battery, microcomputer data storage facility and connection ports for the arrays. The CAVA device will be worn by all participants for 30 days with the aim of capturing eye movement data during a dizzy attack.
The first objective is to develop an algorithm that can discriminate between the 3 listed dizziness conditions. The second is to quantify the financial and patient benefits of deployment in the NHS. The final objective is to expedite a plan to deploy the system in the NHS.
Who can participate
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Inclusion criteria
- ✓. Age 18 and over
- ✓. Must have relevant index medical condition: Ménière's Disease, Vestibular Migraine, posterior canal Benign Paroxysmal Positional Vertigo (see section 6.3.1.2 for specific criteria)
- ✓. Experiencing episodes of true vertigo with at least 2 episodes within the preceding 4 weeks at time of consent
- ✓. The duration and nature of the vertigo is of a duration and a nature supportive of the relevant index medical condition
- ✓. Owns and able to use a telephone
- ✓. Willing to provide informed consent
- ✓. Willing to comply with the study protocol for using the CAVA device
- ✓. Willing to complete all study materials
Exclusion criteria
- ✕. Has an allergy to plasters and/or medical adhesives
- ✕. Evidence of dermatitis, fragile skin, or any other condition that could be aggravated by the repeated application of skin surface adhesives
What they're measuring
1Success of a diagnostic device to diagnose different inner-ear conditions
Timeframe: 30 Days
Trial details
NCT IDNCT05984901
SponsorNorfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2024-10-31
Contact for this trial
John Phillips, PhD