The CAVA Multicentre Dizziness Trial

Summary

The CAVA trial is a diagnostic accuracy multicentre device trial which 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 (BPPV).

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, microcomputer data storage facility and connection ports for the arrays. The CAVA device will be worn by all participants for 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 3 listed dizziness conditions. 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.

Conditions

• Ménière's Disease
• Vestibular Migraine
• Benign Paroxysmal Positional Vertigo (BPPV)

Interventions

DEVICE

The continuous ambulatory vestibular assessment (CAVA) system

The CAVA trial is a diagnostic accuracy multicentre device trial which 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 (BPPV). 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, microcomputer data storage facility and connection ports for the arrays. The CAVA device will be worn by all participants for 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 3 listed dizziness conditions. 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.

Sponsors & Collaborators

• University Hospitals, Leicester

  collaborator OTHER

• St George's University Hospitals NHS Foundation Trust

  collaborator OTHER

• Gloucestershire Hospitals NHS Foundation Trust

  collaborator OTHER

• University Hospital Birmingham NHS Foundation Trust

  collaborator OTHER

• Mid and South Essex NHS Foundation Trust

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Norfolk and Norwich University Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• John Phillips, PhD · Consultant ENT Surgeon

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-01

Primary Completion

2024-10-31

Completion

2025-03-31

Countries

• United Kingdom

Study Locations