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The CAVA Multicentre Dizziness Trial (CAVA 2)

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ClinicalTrials.gov Identifier: NCT05984901
Recruitment Status : Recruiting
First Posted : August 9, 2023
Last Update Posted : August 9, 2023
Sponsor:
Collaborators:
University Hospitals, Leicester
St George's University Hospitals NHS Foundation Trust
Gloucestershire Hospitals NHS Foundation Trust
University Hospital Birmingham NHS Foundation Trust
Mid and South Essex NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
Norfolk and Norwich University Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Ménière's Disease Vestibular Migraine Benign Paroxysmal Positional Vertigo (BPPV) Device: The continuous ambulatory vestibular assessment (CAVA) system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Continuous Ambulatory Vestibular Assessment (CAVA): Development of a System to Provide an Automatic Diagnosis for Vestibular Conditions
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : March 31, 2025


Arm Intervention/treatment
The CAVA Multicentre Dizziness Trial (CAVA2)
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

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.





Primary Outcome Measures :
  1. Success of a diagnostic device to diagnose different inner-ear conditions [ Time Frame: 30 Days ]

    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.)



Secondary Outcome Measures :
  1. Health economics data [ Time Frame: 30 Days ]

    Health economics data will inform analysis of potential financial and patient benefits of a diagnostic pathway incorporating the CAVA system compared to existing pathways. An early cost-effectiveness model will be developed using retrospective patient data.

    The data will be used to estimate the frequency of likely NHS resource-use of patients under observation with one of the three diagnoses, to determine the likely cost and Health-related quality of life impacts of each. It will also be used to assess the prevalence of time-off-work (productivity), reduced productivity and reduce non-paid activities e.g., volunteering, caring etc. as well as insights into early- retirements or changes in occupation etc.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 and over
  2. 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)
  3. Experiencing episodes of true vertigo with at least 2 episodes within the preceding 4 weeks at time of consent
  4. The duration and nature of the vertigo is of a duration and a nature supportive of the relevant index medical condition
  5. Owns and able to use a telephone
  6. Willing to provide informed consent
  7. Willing to comply with the study protocol for using the CAVA device
  8. Willing to complete all study materials
  9. 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05984901


Contacts
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Contact: John Phillips, PhD (+44)01379 788320 ext x5283 john.phillips@nnuh.nhs.uk
Contact: Juliet High +44 (0)1603 59 1708 j.high@uea.ac.uk

Locations
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United Kingdom
Norfolk and Norwich University Hospitals Foundation Trust Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Contact: John Phillips, PhD       john.phillips@nnuh.nhs.uk   
Principal Investigator: John Phillips, PhD         
Sponsors and Collaborators
Norfolk and Norwich University Hospitals NHS Foundation Trust
University Hospitals, Leicester
St George's University Hospitals NHS Foundation Trust
Gloucestershire Hospitals NHS Foundation Trust
University Hospital Birmingham NHS Foundation Trust
Mid and South Essex NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: John Phillips, PhD Consultant ENT Surgeon
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Responsible Party: Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05984901    
Other Study ID Numbers: IRAS: 317899
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vertigo
Meniere Disease
Benign Paroxysmal Positional Vertigo
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Endolymphatic Hydrops