Status:
UNKNOWN
The CAVA Multicentre Dizziness Trial
Lead Sponsor:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborating Sponsors:
University Hospitals, Leicester
St George's University Hospitals NHS Foundation Trust
Conditions:
Ménière's Disease
Vestibular Migraine
Eligibility:
All Genders
18+ years
Phase:
NA
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 dise...
Detailed Description
This is a multicentre diagnostic accuracy study with a recruitment target of 255 adult participants. Recruitment will take place across ten sites in the UK, over two years. To be eligible, participant...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT05984901
Start Date
April 1 2022
End Date
March 31 2025
Last Update
August 9 2023
Active Locations (1)
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1
Norfolk and Norwich University Hospitals Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY