Vestibular conditions Ear, Nose and Throat
Conditions
Interventions
All participants fulfilling the eligibility criteria and providing consent will wear the CAVA device for 30 days in a real-world context. Then the CAVA algorithm will diagnose each patient based only
Sponsors
Norfolk and Norwich University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years and over 2. Must have relevant index medical condition: Ménière’s disease, vestibular migraine, posterior canal benign paroxysmal positional vertigo 3. Experiencing episodes of true vertigo with at least two episodes within the preceding 4 weeks at time of consent 4. The duration and nature of the vertigo is of a duration and a nature supportive of the relevant index medical condition 5. Owns and is able to use a telephone 6. Willing to provide informed consent 7. Willing to comply with the study protocol for using the CAVA device 8. Willing to complete all study materials 9. Adequate grasp of the English language or language used within an existing translated version of the informed consent form and patient information sheet and where hospital translators are available to provide support
Exclusion criteria
Exclusion criteria: 1. Has an allergy to plasters and/or medical adhesives 2. Evidence of dermatitis, fragile skin, or any other condition that could be aggravated by the repeated application of skin surface adhesives 3. Pregnant or breastfeeding mothers 4. Bilateral or second side Ménière’s disease 5. Active bilateral or second side posterior canal benign paroxysmal positional vertigo 6. Currently enrolled on an intervention trial (not including questionnaire-based or observational trial) 7. Patients who meet diagnostic criteria for more than one eligible condition at time of recruitment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of nystagmus data from the device using a computer algorithm; data is collected during the 30 days wearing the device | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety events assessed using adverse event (AE) reporting on Day 5, Day 15, Day 33 2. Health economics measured using a bespoke health economic questionnaire, Social life & Work Impact of Dizziness (SWID) questionnaire and EQ5D3L on Day 0, Day 5, Day 15, Day 33 3. Average time to first dizzy attack determined using device and diary data collected during the 30 days 4. Device compliance measured using device data collected during the 30 days 5. Patient acceptability measured using a tailored user experience questionnaire on Day 33 or at end of participation if earlier 6. Device malfunctions assessed using device data collected during the 30 days 7. Commercialisation informed using the health economics data (post data collection analysis) | — |
Countries
England, United Kingdom
Outcome results
None listed