Benign Paroxysmal Positional Vertigo Clinical Trial
— CAVAOfficial title:
Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Dizziness Trial
Verified date | December 2023 |
Source | Norfolk and Norwich University Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 will capture normal eye movement data as well as data corresponding to any dizzy events experienced. At the end of the trial, the data will be downloaded and a scientist will perform a blinded analysis of the data. Specifically, they will attempt to identify the dates on which dizziness was reported.
Status | Suspended |
Enrollment | 35 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Norfolk & Norwich University Hospitals NHS Foundation Trust | Norwich | Norfolk |
Lead Sponsor | Collaborator |
---|---|
Julie Dawson | University of East Anglia |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nystagmus detection sensitivity and specificity of 95% | The investigators will determine the sensitivity and specificity of the results obtained by a bespoke computer algorithm for detecting episodes of nystagmus, from data captured by the CAVA device. | 30 days | |
Secondary | Post-trial participant questionnaire | A questionnaire will be provided to the participants at the end of the trial to gather data on device acceptability and other patient feedback. A qualitative assessment of this data will be performed. The device acceptability is measured over 8 questions regarding comfort of wear, ease of wear, self consciousness, effect on sleep with each question having a scale of 1-5. With 5 being the best outcome and 1 being the worst outcome. | 30 days | |
Secondary | Compliance with wearing the device | Investigators will check the participants compliance of wearing the device by using the data in the participants' trial diaries. | 30 days | |
Secondary | Functionality of the device's accelerometer | Data will be downloaded from the device and manually checked to ensure that valid data has been captured. | 30 days | |
Secondary | Functionality of the device's event marker | Data will be downloaded from the device and manually checked to ensure that the known dates and times of event marker activation match the record stored on the device. | 30 days | |
Secondary | Functionality of the device's timestamping capabilities | The known dates and times of event marker activations will be compared to the record stored on the device. From this information, clock drift will be calculated (hh:mm:ss). | 30 days |
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