Title: Development of a System to Provide an Automatic Diagnosis for Vestibular Conditions
Funder: Department of Health and Social Care

Abstract: This study will confirm that the Continuous Ambulatory Vestibular Assessment (CAVA) system could be deployed into routine healthcare as an accurate and cost-effective pathway for diagnosing the cause of a patient s vertigo. Dizziness is extremely common. Vertigo is a specific type of dizziness characterised by the subjective sensation of movement. Diagnosing the cause of vertigo is challenging because self-reporting is ambiguous, vertigo is momentary, and there are no objective clinical tests. We have developed the CAVA system to provide a thirty-day record of the physiological parameters required to confirm the presence of the eye-movements accompanying vertigo (nystagmus). Our proof-of-concept work has shown that common causes of vertigo can be discriminated using the data it provides. A preliminary economic analysis has revealed potential cost-savings of &pound;1,328, per patient. This study aims to quantify the extent to which the CAVA system can differentiate three common inner-ear causes of dizziness: M&eacute;ni&egrave;re s disease, vestibular migraine and Benign Paroxysmal Positional Vertigo (BPPV). The first objective is to extend the system to discriminate between these diseases. 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. Our objectives will be achieved through a diagnostic accuracy study involving 400 adult participants, 85 per target disease (minimum), each wearing the CAVA device for thirty days. Each patient s diagnosis will form the &ldquo;reference standard&rdquo; which we will later compare with our automated computer diagnosis. Using computer algorithms developed to differentiate the target diseases, based on the data from the CAVA devices, we will compare each computer predicted diagnosis with the &ldquo;reference standard label&rdquo;. The accuracy of the system will be quantified using sensitivity, specificity and Receiver Operator Curves. This three-year study is divided into three work-packages. After a six-month setup during which regulatory approvals are sought, a two-year clinical investigation begins. Two months at the end of the study are for analysis and writeup. A work-package of Health Economics is divided into three, six-month periods. We will work with a commercialisation expert to develop our deployment strategy, supplemented by a stakeholders event in the last six months of the project. After three years, we will have identified candidate licensees who could formally manufacture the system. This study will demonstrate the clinical applicability and potential benefits of the CAVA system to clinicians, the public and potential licensees. It will show that the system could improve the speed of access to targeted treatment, reducing the physical and mental suffering of patients, and delivering cost and time efficiency savings to the NHS. We project a timeline of three years after completion in which these benefits will be realised. We will update our website with our progress and findings, and participants will be directed to this resource and invited to contribute their experiences. We will present our work at academic conferences, in journal publications, and will take part in media opportunities to raise awareness of our work to all sections of society.

Lay abstract: Dizziness is an extremely common complaint. For some patients, dizziness is an unpredictable, violent spinning sensation that lasts for many hours. Such attacks leave patients feeling sick and exhausted. Dizziness comes and goes and is therefore difficult to diagnose as patients usually visit their doctor in between attacks, when examination is normal. There can be many causes of dizziness, but there are few conclusive medical tests. For common inner-ear causes of dizziness, the correct diagnosis makes the difference between being treated with physiotherapy, surgery, or a course of drugs. Patients will see several doctors before receiving a correct diagnosis. We estimate the cost of non-emergency NHS appointments to be up to &pound;1,328, per patient. There is a clear need to quickly and accurately diagnose and treat patients with dizziness. With funding from the Medical Research Council, we have developed the &ldquo;CAVA&rdquo; system: a medical device worn around the head and computer software which together can confirm the source of dizziness attacks. The device works by recording eye movements and head movements of a patient during their normal daily activities, for a period of thirty-days. This approach is similar to the way to that 24-hour heart monitors are used to diagnose heart conditions. The device is safe, patients are happy to wear it, and it can accurately detect the eye-movements necessary for doctors to confirm dizziness. We have captured data showing clear differences between the eye-movements produced by three of the most common inner-ear causes of dizziness. We now intend to further develop our system to determine how accurately our system performs, with the view to making it accessible to NHS patients at the earliest possible opportunity. 400 patients with a diagnosis will wear our device for thirty-days and the CAVA system will diagnose each patient based only on the data from the device. We will assess the system s accuracy by comparing the CAVA system s diagnosis with each patient s known diagnosis. We will also quantify the potential health benefits to patients and the economic benefits of deploying our system into routine NHS healthcare. Patients and carers have been involved in the design of our first trials, the design of the device, and now in the design of this application. We have sought participant feedback during our trials and will continue to do so in future to ensure that our goals align with patient expectations. We have CE-marked our system and it is protected by patent applications. These are vital steps towards deploying it into routine NHS care. We will continue to share our work among scientific communities and the public, and will seek industrial partners who can successfully deliver the benefits of the CAVA system to both patients and the NHS.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: NEUROLOGICAL;EAR