The continuous ambulatory vestibular assessment (CAVA) multicentre dizziness trial
| ISRCTN | ISRCTN81218533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81218533 |
| IRAS number | 317899 |
| Secondary identifying numbers | CPMS 54262, IRAS 317899 |
- Submission date
- 27/01/2023
- Registration date
- 31/01/2023
- Last edited
- 10/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
Dizziness is common and identifying the condition causing it is challenging. This can lead to patients experiencing significant delays in diagnosis. The aim of this study is to test the CAVA system’s ability to use eye movement data collected by the device to diagnose dizziness conditions. This could greatly reduce the time to diagnosis saving the NHS money by reducing multiple visits to GP clinics, referrals to specialists and the number of treatments required.
Who can participate?
Adults who have been diagnosed with Meniere’s disease, vestibular migraine or benign paroxysmal positional vertigo (BPPV) and currently experiencing episodes of vertigo/dizziness.
What does the study involve?
The study involves wearing a device that goes over the ear and attaches to the face for 30 consecutive days whilst logging dizziness symptoms in a diary. There will be up to five in-person hospital visits to learn how to use the device and complete questionnaires.
What are the possible benefits and risks of participating?
Benefits include helping conduct the research around identifying dizziness conditions using the CAVA device. Risks include some redness caused by the electrode pads attaching to the skin.
Where is the study run from?
The study is run from the Norfolk and Norwich University Hospital and the University of East Anglia (UK)
When is the study starting and how long is it expected to run for?
July 2022 to October 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Dr Gregory M Howard, Gregory.howard@uea.ac.uk
Contact information
Scientific
Norwich Clinical Trials Unit
Norwich Medical School
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
 ORCID ID |
0000-0001-5749-0782 |
|---|---|
| gregory.howard@uea.ac.uk |
Principal Investigator
Norfolk & Norwich University Hospital NHS Trust
Colney Lane
Norwich
NR4 7UY
United Kingdom
| ORCID ID |
0000-0001-7886-6283 |
|---|---|
| john.phillips@nnuh.nhs.uk |
Study information
| Study design | Non-randomized; Both; Design type: Diagnosis, Device, Validation of outcome measures |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Continuous ambulatory vestibular assessment (CAVA) - development of a system to provide an automatic diagnosis for vestibular conditions |
| Study acronym | CAVA |
| Study objectives | The CAVA System will identify and differentiate nystagmus using the algorithm. |
| Ethics approval(s) | Approved 24/10/2022, West Midlands – South Birmingham REC (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 (0)207 104 8345, +44 (0)207 104 8068, +44 (0)207 104 8143; southbirmingham.rec@hra.nhs.uk), ref: 22/WM/0229 |
| Health condition(s) or problem(s) studied | Vestibular conditions |
| Intervention | 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 on the data recorded from the device. The accuracy of the system will be tested by comparing the CAVA system’s diagnosis with each patient’s known diagnosis. All participants will be provided with the PIS after confirmation of eligibility at Visit 1. They will receive training on how to wear the monitoring device and how to use and care for it at the hospital at Visit 2 (Day 0). Once competency in the use of the CAVA system is demonstrated participants will be asked to wear the device for 30 consecutive days, 23 hours each day. At Visit 3 (Day 5) participants will return to the hospital to assess adherence and adverse reactions. The battery will need to be replaced around halfway through the 30 days so participants will return to the hospital for Visit 4 (Day 15) to have the battery changed, assess adherence and adverse events. Also at Visit 4 any participants with benign paroxysmal positional vertigo (BPPV) will receive treatment whilst wearing the device. The participants will return to the hospital for Visit 5 (Day 33) to return the device and all accessories as well as complete a questionnaire. Participants will replace the electrode pads on a daily basis during their participation. The device has an ‘event marker’ button to be used when a patient experiences dizziness. The patient would press this button to effectively mark the data denoting an episode of dizziness. Support and advice will be provided by the research team to deal with any concerns which arise from using the CAVA system. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | CAVA device |
| Primary outcome measure | Identification of nystagmus data from the device using a computer algorithm; data is collected during the 30 days wearing the device |
| Secondary outcome measures | 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) |
| Overall study start date | 01/07/2022 |
| Completion date | 31/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 255 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/02/2023 |
| Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Colney
Norwich
NR4 7UY
United Kingdom
Worthing
BN11 2DH
United Kingdom
Tooting
London
SW17 0QT
United Kingdom
London
SE1 7EH
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Leicester
LE1 5WW
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Westcliff-on-sea
SS0 0RY
United Kingdom
Sponsor information
Hospital/treatment centre
Colney Lane
Colney
Norwich
NR4 7UY
England
United Kingdom
| Phone | +44 (0)1603647882 |
|---|---|
| julie.dawson@nnuh.nhs.uk | |
| Website | http://www.nnuh.nhs.uk/ |
"ROR" |
https://ror.org/01wspv808 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 07/11/2024 | 20/11/2024 | Yes | No |
Editorial Notes
10/06/2025: The following changes were made:
1. The overall study end date was changed from 30/06/2025 to 31/10/2025.
2. The recruitment end date was changed from 31/01/2025 to 31/08/2025.
20/11/2024: Publication reference added.
07/10/2024: The recruitment end date was changed from 30/10/2024 to 31/01/2025.
21/02/2023: The recruitment start date was changed from 01/11/2022 to 21/02/2023.
27/01/2023: Trial's existence confirmed by the NIHR.
