Status:
SUSPENDED
CAVA: Dizziness Trial
Lead Sponsor:
Julie Dawson
Collaborating Sponsors:
University of East Anglia
Conditions:
Meniere's Disease
Benign Paroxysmal Positional Vertigo
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Clinical investigation of a medical device (CAVA) for recording eye movements. Patients suffering from diagnosed dizziness conditions will wear the device for 23 hours a day, for 30 days. The device w...
Detailed Description
Dizziness is a common condition that is responsible for a significant degree of material morbidity and burden on our health service. There are multiple causes of dizziness, and these originate from pa...
Eligibility Criteria
Inclusion
- Adults aged 18 and over.
- Patients experiencing episodes of true vertigo, with at least two episodes within the preceding month. Relevant medical conditions include Meniere's disease, Benign Paroxysmal Positional Vertigo (BPPV), recurrent vestibulopathy and vestibular migraine.
- Able to commit to 30 days of continuous wear of the trial device as per the study plan.
- Own a telephone.
Exclusion
- Potential participants who have a history of dermatological disease, fragile skin, or damage around the forehead.
- Potential participants who have an allergy to plasters and/or medical adhesives - (similarly to materials used in the device).
- History of hypertension or cardiac problems (uncontrolled, acute or de-compensated - phase).
- History of ear disease, or previous ear surgery.
- History of psychotic/neurotic disorders or epilepsy.
- History of eye disease, or previous eye surgery.
- Pregnant or nursing mothers.
- Potential participants who have taken part in a previous CAVA trial.
- Potential participants who are currently taking part in another trial.
- Unable to follow the testing protocol.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04026516
Start Date
July 1 2019
End Date
May 31 2025
Last Update
December 22 2023
Active Locations (1)
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1
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY