Development of the continuous ambulatory vestibular assessment (CAVA) system to provide an automatic diagnosis for vestibular conditions: protocol for a multicentre, single-arm, non-randomised clinical trial

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INTRODUCTION: Dizziness is a common symptom that can occur in an unpredictable and episodic manner leading to the imprecise reporting of symptoms. Patients will often see many specialists before receiving a diagnosis and treatments can vary in terms of risk and invasiveness which places a significant burden on health services. Achieving an early precise diagnosis could be key in reducing the impact of symptoms on patients and health services. METHODS AND ANALYSIS: The continuous ambulatory vestibular assessment (CAVA) trial is a single-arm, non-randomised, multicentre diagnostic accuracy device trial that 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. 85 participants with an established diagnosis from each of the three dizziness conditions, a total of 255 participants, will be recruited from ear, nose and throat, audiology and audiovestibular medicine departments in National Health Service (NHS) sites across the UK. 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, a data storage facility and connection ports for the arrays. The CAVA device will be worn by all participants for up to 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 three dizziness conditions listed above. 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. ETHICS AND DISSEMINATION: The trial was approved by the West Midlands-South Birmingham Research Ethics Committee and the Medicines and Healthcare products Regulatory Agency (MHRA). REC reference: 22/WM/0229, IRAS Project ID: 317899, and MHRA: CI/2022/0062 /GB. Participants will provide full informed consent and can withdraw for any reason without it affecting their standard care. Dissemination will include publication in peer-reviewed journals, presentations at academic and public conferences including patients and the public and to policymakers and practitioners. TRIAL REGISTRATION NUMBER: ISRCTN81218533, trial protocol V.3.1 (25 January 2024).

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