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
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 255 participants or records.
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