The CAVA Multicentre Dizziness Trial

NCT05984901 | Unknown

• 1 other identifier: IRAS: 317899
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Success of a diagnostic device to diagnose different inner-ear conditions

  The primary outcome is the success of a diagnostic device to diagnose different inner-ear conditions appraised by calculating values for sensitivity and specificity. Head and eye movements recorded by the CAVA device will enable the computer algorithms (to be developed) to differentiate between the three target conditions. The investigators will develop computer algorithms that use the data captured by the CAVA devices to differentiate between the three target conditions. The algorithms use deep learning neural networks (DNNs) in a so-called 'end-to-end' approach. In this approach, a multi-layered network takes as input 'raw' time domain data and outputs a classification decision without using any explicit intermediate representations of the signal (such as signal entropy, power, skewness, kurtosis etc.)

  30 Days

Secondary Outcomes (1)

• Health economics data

  30 Days

Study Arms (1)

The CAVA Multicentre Dizziness Trial (CAVA2)

OTHER

CAVA 2 is a single arm study testing a diagnostic device to diagnose different inner-ear conditions appraised by calculating values for sensitivity and specificity. Head and eye movements recorded by the CAVA device will enable the computer algorithms (to be developed) to differentiate between the three target conditions.

Device: The continuous ambulatory vestibular assessment (CAVA) system

Interventions

The continuous ambulatory vestibular assessment (CAVA) system DEVICE

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.

The CAVA Multicentre Dizziness Trial (CAVA2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and over
• Must have relevant index medical condition: Ménière's Disease, Vestibular Migraine, posterior canal Benign Paroxysmal Positional Vertigo (see section 6.3.1.2 for specific criteria)
• Experiencing episodes of true vertigo with at least 2 episodes within the preceding 4 weeks at time of consent
• The duration and nature of the vertigo is of a duration and a nature supportive of the relevant index medical condition
• Owns and able to use a telephone
• Willing to provide informed consent
• Willing to comply with the study protocol for using the CAVA device
• Willing to complete all study materials
• Adequate grasp of the English language or language used within an existing translated version of the informed consent form and patient information sheet and where hospital translators are available to provide support

You may not qualify if:

• Has an allergy to plasters and/or medical adhesives
• Evidence of dermatitis, fragile skin, or any other condition that could be aggravated by the repeated application of skin surface adhesives
• Pregnant or breastfeeding mothers
• Bilateral or second side Ménière's Disease
• Active bilateral or second side posterior canal Benign Paroxysmal Positional Vertigo
• Currently enrolled on an intervention trial (not including questionnaire-based or observational trial)
• Patients who meet diagnostic criteria for more than one eligible condition at time of recruitment

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead
• University Hospitals, Leicester: collaborator
• St George's University Hospitals NHS Foundation Trust: collaborator
• Gloucestershire Hospitals NHS Foundation Trust: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• Mid and South Essex NHS Foundation Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

Norfolk and Norwich University Hospitals Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Meniere Disease; Benign Paroxysmal Positional Vertigo

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Vertigo; Vestibular Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• John Phillips, PhD

  Consultant ENT Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Phillips, PhD

CONTACT

(+44)01379 788320; john.phillips@nnuh.nhs.uk

Juliet High

CONTACT

+44 (0)1603 59 1708; j.high@uea.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants fulfilling the eligibility criteria and providing consent will wear the CAVA device for 30 days. The CAVA algorithm will then diagnose each patient based only on the data recorded from the device. The accuracy of the system will be tested by comparing the CAVA system's diagnosis with each patient's known diagnosis. The results of the algorithm work ("the diagnosis") will not be available until the end of the trial and will not be made available to clinicians or patients during the trial.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: August 9, 2023
• Study Start: April 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: March 31, 2025
• Last Updated: August 9, 2023

Record last verified: 2023-03

Locations

GB (1)