Production of a device to obtain continuous ambulatory vestibular assessment (CAVA)

Lead Research Organisation: University of East Anglia
Department Name: Norwich Medical School

Abstract

In England and Wales, 8 out of every 1,000 patients are likely to consult their GP complaining of dizziness every year. Dizziness is the most common reason for a doctor to visit a patient over the age of 75 years old, and one-third of adults over the age of 65 years experiences at least one fall each year. This is particularly important as the cost of falls to the NHS and social services in people over 60 years old in 1999 was £981 million. However, we are currently significantly restricted with respect to what specialist tests are available for assessing patients with dizziness, because there are no tests available to evaluate a patient during an actual dizziness attack in the community. If this were possible, an accurate diagnosis could be made there and then, rather than speculating as to what the cause of the dizziness attack was days or weeks after the event when the patient has recovered. The US National Institutes of Health reports that the average number of doctors that a patient with dizziness visits before receiving a correct diagnosis is 4.5, and a similar finding is reported from specialist balance centers in the UK. We have developed and successfully tested a prototype body worn device to diagnose the cause of dizziness in the community, and are applying to the Medical Research Council to fund the next stage of device development. Once fully developed and tested in clinical studies, it is hoped that our device will be made available at the point of initial referral to a doctor or nurse to avoid delay in diagnosis and ensure cost-effective use of appropriate resources.

Our current prototype device is only partly developed, and as such currently requires the involvement of a large, bulky and uncomfortable to wear module; as it has been constructed using unrefined electronics and off the shelf materials to prove that it is a viable concept. Our application to the Medical Research Council is to fund the development of a complete bespoke device that would be a lightweight, durable, body worn monitoring device that could be worn day and night. In addition to this, funding from the Medical Research Council would support the development of specialist computer software to analyse the data produced by our refined device.

Technical Summary

Dizziness is a common condition that is responsible for a significant degree of material morbidity and burden on our health service. There are multiple causes of dizziness, and these originate from pathologies affecting a large variety of different organ systems. Dizziness is usually episodic and short-lived, so when a patient presents to their health care provider, examination is often normal. As such, diagnosis is challenging and patients often experience significant delay in receiving a diagnosis. We have developed a prototype device for monitoring dizziness and have tested it in a small group of volunteers. The results showed that our device is capable of accurately, precisely and reliably identifying periods of dizziness over a short period of time. Independent market research has confirmed that our device could meet the required clinical need, would be desired by clinicians, and that there is no equivalent solution currently available. We seek funds to trial our device in a large cohort of healthy volunteers and a large cohort of patients with a defined dizziness syndrome. We will then be positioned well to test our device in a more diverse patient population. Once validated, developed and brought to market, the device would provide early diagnosis and accurate treatment for a significant proportion of the patient population. This would save the NHS money by reducing multiple visits to GP clinics, reducing referrals to multiple specialist clinics, and reducing treatment required from falls and other conditions associated with dizziness.

Planned Impact

This research will benefit patients, clinicians, healthcare systems (NHS) and researchers who are interested in gaining greater insight into the causes and mechanisms responsible for many balance disorders and types of dizziness conditions. Patients will benefit from a quicker and more accurate definition of the cause of their symptoms. Clinicians will benefit from having a clearer understanding of the cause of their patient's symptoms earlier on in the diagnostic process. Healthcare systems will save money by reducing the number of patient consultations required before a diagnosis is made, and avoid the use of unnecessary expensive specialist tests. Governments would be able to implement amended patient pathways allowing a greater transition from hospital-centered care to a more cost-effective community-based concept of care.

Dizziness is the most common reason for a physician to visit a patient over the age of 75 years old, and one-third of adults over the age of 65 years experiences at least one fall each year. There is great potential in improving the direct health of patients with dizziness, but also indirectly improve the health of patients be reducing the risk of falling, particularly in the elderly. The cost of falls to the NHS and social services in people over 60 years old in 1999 was £981 million. In addition to this, balance disorders are responsible for work absence, early retirement and a significant reduction in quality of like. The development of this device will contribute to the nation's health culture by promoting diagnostic investigations to be performed outside the hospital or surgery environment.

Other beneficiaries include, private health care companies, technology companies and UK businesses that may be involved in the various roles associated with the manufacture, marketing and promotion of this device. As a new diagnostic tool, a whole new field of balance medicine may be created, allowing further research into balance disorders from a perspective never appreciated before. This will promote further research into balance disorders that have been derived from the primary outcomes of our initial research performed using this device.

This application is for a key stage in the development of our device, for use and testing in healthy individuals and in patients with a specific dizziness syndrome. The timescale for some of the benefits of this device will be realised by the end of duration of this grant (36 months), and a full working device would be available for further clinical trials in an undiagnosed population of patients. The full benefits of this device is likely to be fully realised in 3 to 5 years.

The research associate employed on this project will develop skills in both research and other professional areas. In research, he or she will learn how to plan and execute a research project, from reviewing literature to posing research questions to formulating experiments and interpreting results. In doing the research, he or she will develop their knowledge of machine-learning and pattern recognition theory and techniques, and also strengthen and expand their programming skills. In the latter stages of the project, he or she will develop their understanding and knowledge of app programming for mobile devices, which is a skill that is currently sought after in many different areas of industry. Overall, he or she will also learn how to participate in a project team as a technical member and how to contribute to the development of a project as a leader, managing a variety of individual project components.

Publications

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Description i4i
Amount £125,869,200 (GBP)
Funding ID NIHR202870 
Organisation University of East Anglia 
Sector Academic/University
Country United Kingdom
Start 04/2022 
End 03/2025
 
Description sCAVA - Sleep Assessment Using the CAVA Device
Amount £63,164 (GBP)
Organisation University of East Anglia 
Sector Academic/University
Country United Kingdom
Start 10/2019 
End 04/2020
 
Title CAVA Healthy Volunteer Database 
Description 17 participants wore the CAVA device for up to 24 hours a day, for up to 30 days. The dataset contains horizontal and vertical eye movement data, head movement data, and several useful status signals (e.g. battery status, user event marking, timestamping). The data was captured during a clinical investigation involving healthy volunteers. During the investigation, on up to eight occasions, participants artifiically induced nystagmus (the eye movement produced during dizziness) by way of viewing a video stimulus. This dataset was designed to be used as part of a blinded experiment, in which the eight days from each participant were to be identified automatically by a specially developed computer algorithm. 
Type Of Material Database/Collection of data 
Year Produced 2018 
Provided To Others? No  
Impact The database was used to test our computer algorithms, the results from which determined the success of our clinical investigation. The results proved that the device records good quality data, it functions as intended, and that the algorithms developed are capable of detecting the visually-induced nystagmus. 
 
Title CAVA Nystagmus Detection Software 
Description Using the data from the CAVA device, the algorithm developed can be used to detect automatically periods of visually-induced nystagmus. The system can also detect some more detailed features of nystagmus, including the fundamental frequency of the signal, and the "beat direction". 
Type Of Material Computer model/algorithm 
Year Produced 2018 
Provided To Others? No  
Impact The algorithm developed has been evaluated using the data captured during our clinical investigation on healthy volunteers. The results indicated that the algorithm works as intended and with promising levels of accuracy. The accuracy attained was sufficient to meet the MRC's success criteria, allowing us to conduct a further study on patients suffering from dizziness and to develop and test the algorithm on the data produced by that trial. The algorithm also demonstrated that the CAVA device itself is capable of providing data of a sufficient quality to allow the detection of short periods of nystagmus buried within days worth of data. 
 
Description sCAVA - Sleep assessement using the CAVA device 
Organisation University of East Anglia
Country United Kingdom 
Sector Academic/University 
PI Contribution Working with a sleep scientist, we are using our data and our expertise to develop algorithms for analysing the architecture of sleep.
Collaborator Contribution Our partner provides expertise in sleep analysis and also the facilities (sleep lab and equipment) to undertake a pilot study.
Impact We have received £~63k from the UEA's Innovation Development Fund to conduct a pilot study to explore the use of the CAVA device for analysing the arcitecture of sleep. This is a multidisciplinary project encompassing medicine, health sciences (specifically, sleep) and computer science.
Start Year 2019
 
Title Registered designs of earpiece and electrode mounts 
Description The physical appearance (designs) of the earpiece and electrode mounts have been regisered in the UK. The design numbers 6039096 and 6039097. 
IP Reference  
Protection Copyrighted (e.g. software)
Year Protection Granted 2018
Licensed No
Impact N/A
 
Title The "CAVA" name 
Description We have filed the name "CAVA" in four relevant trademark categories (9, 10, 42, 44). 
IP Reference  
Protection Trade Mark
Year Protection Granted 2018
Licensed No
Impact N/A. We simply wished to protect the name of the device. CAVA (Continuous Ambulatory Vestibular Assessement) has a clear and precise meaning, which is well suited to the device we have developed.
 
Title CAVA: Healthy Volunteer Trial 
Description We have developed a medical device to be worn by participants suffering from dizziness. The device is worn for 30 days, during which time it continuously records eye and head movement data. At the end of the monitoring period, a clinician would use the data on the device to inform a diagnosis. Supporting computer algorithms have been developed to highlight irregular (nystagmus) eye movements to the clinician, which would indicate the presence of a dizzy attack. The MRC has funded this project in full, and the device is currently an advanced prototype. The device was deployed in a clinical investigation on healthy volunteers to evaluate its suitability for long-term wear and capability for vestibular telemetry. 
Type Management of Diseases and Conditions
Current Stage Of Development Initial development
Year Development Stage Completed 2018
Development Status Under active development/distribution
Clinical Trial? Yes
Impact The clinical investigation on healthy volunteers was completed successfully, confirming that our device is fit for purpose. The device recorded good quality data which could be used to identify artificially induced periods of nystagmus with high accuracy, and participants were generally very accepting of wearing the device. Following these results, we will hold an investigation involving patients suffering from dizziness conditions, to test our device on actual rather than simulated nystagmus. 
URL http://www.cava-project.com
 
Title CDT: CAVA Dizziness Trial 
Description We have developed a medical device to be worn by participants suffering from dizziness. The device is worn for 30 days, during which time it continuously records eye and head movement data. At the end of the monitoring period, a clinician would use the data on the device to inform a diagnosis. Supporting computer algorithms have been developed to highlight irregular (nystagmus) eye movements to the clinician, which would indicate the presence of a dizzy attack. The MRC has funded this project in full, and the device was deployed in a clinical investigation on healthy volunteers to evaluate its suitability for long-term wear and capability for vestibular telemetry. Having successfully completed that trial, this latest trial seeks to evaluate the device on patients suffering from pathological dizziness. 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Initial development
Year Development Stage Completed 2019
Development Status Under active development/distribution
Clinical Trial? Yes
Impact The clinical investigation on healthy volunteers was completed successfully, confirming that our device is fit for purpose. The device recorded good quality data which could be used to identify artificially induced periods of nystagmus with high accuracy, and participants were generally very accepting of wearing the device. Following these results, we are now undertaking an investigation involving patients suffering from real dizziness, to test our device on actual rather than simulated nystagmus. 
URL https://clinicaltrials.gov/show/NCT04026516
 
Title CAVA device 
Description Working with a design agency (Wright Design Limited), we have successfully designed, developed and produced a fully functional medical prototype device for appraising dizziness. The CAVA device captures the corneo-retinal potential (CRP) between the back and front of each eye, which changes as the eye moves and hence is a proxy for eye movement. The device consists of a logging module which sits behind the left ear, and two single-use electrode mounts which attach to each side of the face. The device is small, lightweight, durable, easy to apply and requires minimal user intervention during operation. The device also contains a three-axis accelerometer, which simultaneously records the accelerative forces experienced by the head. An event marker button is present on the device to allow the subject to log events of interest (such as experiencing dizziness), for which the device records the date and time of the button press. The device is intended to be worn continuously for up to thirty days, after which the data would be downloaded by a clinician and reviewed (manually and automatically) for evidence of the eye movements associated with dizzy events. 
Type Of Technology New/Improved Technique/Technology 
Year Produced 2018 
Impact This advanced prototype was deployed on a clinical investigation to evaluate its suitability for the task of continous data capture. This investigation involved healthy volunteers and successfully proved that the concept of vestibular telemetry is a viable one. Following this study, we have secured the funding for the second half of our MRC funded project, during which we will evaulate our device on patients suffering from dizziness conditions. 
URL http://www.cava-project.org
 
Company Name CAVA DIAGNOSTICS LIMITED 
Description This company was formed to act as the legal manufacturer of the CAVA system for the purpose of applying a CE mark. 
Year Established 2020 
Impact Not applicable.
 
Description Article in Norfolk & Norwich Hospital's Pulse Magazine 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact In August 2018, the Norfolk & Norwich Hospital featured the CAVA project in the 87th issue of Pulse magazine. This issue featured a front-page picture of the project team, and a two-page article describing details of the project and the device itself. Following this article and the radio interview, the CAVA team received a significant amount of interest from dizzy sufferers wishing to be involved in the project.
Year(s) Of Engagement Activity 2018
URL http://www.nnuh.nhs.uk/publication/pulse-august-2018-the/
 
Description Article in October's issue of Norfolk & Norwich Hospital's Pulse Magazine 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact In October 2019, the Norfolk & Norwich Hospital featured the CAVA project in the 94th issue of Pulse magazine. This issue featured a front-page picture of the CAVA device worn by John Phillips, and a one-page article describing details of the project, the device itself and showing a picture of the project team.
Year(s) Of Engagement Activity 2019
URL https://issuu.com/nnuhcommunications/docs/october_2019_pulse_final_pages
 
Description Department Seminar in School of Computing Sciences at University of East Anglia 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Members of the School of Computing Sciences at UEA attended a seminar given by Dr Jacob Newman. The seminar shared the progress of the CAVA project to date, focussing on the Computer Science aspects of the work undertaken. As a result of questions asked and comments made by the audience, the research team revisited the use Deep Neural Networks for the task of nystagmus detection.
Year(s) Of Engagement Activity 2020
URL http://sites.uea.ac.uk/computing/news-and-events/seminars/-/asset_publisher/a9l6p5FXwXPI/blog/contin...
 
Description Interview by Radio Norfolk 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact In August 2018, John Phillips was interviewed by Radio Norfolk about the CAVA project. He discussed the details of the project, highlighted that the MRC had funded the project in full, and also explained that the project is a collaboration between the University of East Anglia (UEA), the Norfolk & Norwich University Hospital (NNUH) and Wright Design Limited.
Year(s) Of Engagement Activity 2018
 
Description Patient and Public Involvement Exercise 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Patients, carers and/or patient groups
Results and Impact In November 2017, we held a meeting with five patients who had suffered from a dizziness condition called Ménière's disease. The purpose of this meeting was to present our initial design concepts to actual dizziness sufferers, in order to gather their opinions and suggestions on the possible approaches presented. We received rich feedback from the patients, who described in detail the debilitating symptoms of their dizzy attacks, the practical and social implications of having an attack, and their thoughts on our proposed solutions.

There was unanimous agreement amongst the patients that they would wear the proposed device for thirty days if it could lead to being diagnosed more quickly, and therefore being given faster access to treatment. The patients were not concerned about applying, removing and maintaining the device, even with limited assistance. Most participants expressed a preference for a device that sits behind the ear, similar to a hearing aid. Patients repeatedly highlighted that they considered most issues discussed to be secondary to the severe discomfort of dizziness symptoms; even the physical appearance of the device. As one participant succinctly put it, "I would wear a gorilla costume". Following the meeting, the feedback from the patients was considered carefully by both the design agency and the project team. The meeting confirmed that there was a strong requirement for the development of the CAVA device, and the sentiment expressed by the participants during the meeting provided an encouraging indication that the approach adopted by the CAVA team was appropriate.
Year(s) Of Engagement Activity 2017
 
Description Patient and Public Involvement Exercise to discuss CAVA's future plans 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Patients, carers and/or patient groups
Results and Impact 4 patients attended a virtual PPI event with two members of the CAVA project team. The event aimed to find the patients' comments and suggestions on the team's plans for future research related to the CAVA project. As a result of the discussions, the CAVA team made changes to the structure and language used in a grant application for further funding.
Year(s) Of Engagement Activity 2020
 
Description Radio interview on BBC Radio Birmingham 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact John Phillips was interviewed by BBC Radio Birmingham about vertigo, The Meniere's Society and the CAVA project.
Year(s) Of Engagement Activity 2019
 
Description Seminar in the Ear Nose & Throat Department at the Norfolk and Norwich University Hospital 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact A 30-minute presentation given by Dr Jacob Newman to medical staff in the Ear, Nose & Throat department. The presentation discussed the progress of the CAVA project, focussing on the findings from the first clinical investigation involving the CAVA device, and recent clinical findings. Detailed discussions followed the talk, with many questions asked about the underlying technology and the potential applications of the CAVA device. The increased awareness of the project among the NNUH staff led to referrals of new patients to CAVA's second trial involving patients with dizziness.
Year(s) Of Engagement Activity 2020
 
Description The Engaging Images Exhibition 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact The Engaging Images exhibition is a display of inspiring scientific photographs that tell the story of the ground-breaking research being carried out across the Norwich Research Park. An image of PI John Phillips wearing the CAVA device was one of the winning images selected for display during the Norwich Science Festival. At this event, John Phillips gave a short oral presentation about the CAVA project to the general public and the other exhibitors. Following this, he and Jacob Newman answered general questions from the public during a "Meet the Scientists" session.
Year(s) Of Engagement Activity 2019
URL https://norwichsciencefestival.co.uk/events/engaging-images/