Condition or disease | Intervention/treatment | Phase |
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Meniere's Disease Benign Paroxysmal Positional Vertigo Recurrent Vestibulopathy Vestibular Migraine | Device: CAVA Device | Not Applicable |
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 pathologies affecting a large variety of different organ systems. Dizziness is usually episodic and short-lived, so when a patient presents to their health care provider, examination is often normal. As such, diagnosis is challenging and patients often experience significant delay in receiving a diagnosis.
The investigators have developed a prototype device for monitoring dizziness and have tested it in a group of 17 healthy volunteers. The results showed that their device is capable of accurately, precisely and reliably identifying short periods of induced nystagmus (eye movements produced during dizzy attacks) among days' worth of normal eye movement data.
The overall aim of this trial is to test a fully evolved device for the continuous recording of eye movements over a prolonged period of time, on patients suffering from dizziness. For the purpose of this study, the monitoring period is 23 hours a day, for 30 days. The device is composed of two components: a bespoke single-use sensor array that adheres to the participant's face, and a small reusable module that contains a battery, microcomputer, data storage facility, battery and connection port.
The investigators intend to confirm that the device data can be used to identify any occurrence of nystagmus, as produced during attacks of vertigo. Each trial participant will be provided with the device and enough single-use electrode arrays to allow the array to be changed every 24 hours, for thirty days. Participants will be allowed to remove the sensor array for up to 60 minutes each day to allow them to wash and/or shower. If patients experience an episode of dizziness during the trial, they are required to log the details of the event in a trial diary. The identity of these days will not be revealed to the blinded investigator who will later conduct a formal, blinded analysis of the data. At the end of the thirty-day trial, the sensitivity and specificity of the device will be determined by assessing whether the data can be used to correctly identify the dates that participants reported dizziness.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 35 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Dizziness Trial |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | October 31, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: CAVA Dizziness Trial Arm
All trial participants are within this arm. All participants will wear the CAVA device for 30 days and follow the same procedures throughout the trial.
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Device: CAVA Device
The CAVA device will be worn continuously for thirty days, during which time it will record eye and head movements
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adults aged 18 and over.
Exclusion Criteria:
Contact: John Phillips, Consultant | +44 1603 593054 | john.phillips@mac.com | |
Contact: Jacob Newman, Dr | +44 1603 593054 | jacob.newman@uea.ac.uk |
United Kingdom | |
Norfolk & Norwich University Hospitals NHS Foundation Trust | Recruiting |
Norwich, Norfolk, United Kingdom, NR4 7UY | |
Contact: Julie Dawson, Mrs +44 1603 286611 julie.dawson@nnuh.nhs.uk |
Principal Investigator: | John Phillips, Consultant | Dr |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 8, 2019 | ||||||||
First Posted Date ICMJE | July 19, 2019 | ||||||||
Last Update Posted Date | October 8, 2020 | ||||||||
Actual Study Start Date ICMJE | July 1, 2019 | ||||||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Nystagmus detection sensitivity and specificity of 95% [ Time Frame: 30 days ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | CAVA: Dizziness Trial | ||||||||
Official Title ICMJE | Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Dizziness Trial | ||||||||
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 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. | ||||||||
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 pathologies affecting a large variety of different organ systems. Dizziness is usually episodic and short-lived, so when a patient presents to their health care provider, examination is often normal. As such, diagnosis is challenging and patients often experience significant delay in receiving a diagnosis. The investigators have developed a prototype device for monitoring dizziness and have tested it in a group of 17 healthy volunteers. The results showed that their device is capable of accurately, precisely and reliably identifying short periods of induced nystagmus (eye movements produced during dizzy attacks) among days' worth of normal eye movement data. The overall aim of this trial is to test a fully evolved device for the continuous recording of eye movements over a prolonged period of time, on patients suffering from dizziness. For the purpose of this study, the monitoring period is 23 hours a day, for 30 days. The device is composed of two components: a bespoke single-use sensor array that adheres to the participant's face, and a small reusable module that contains a battery, microcomputer, data storage facility, battery and connection port. The investigators intend to confirm that the device data can be used to identify any occurrence of nystagmus, as produced during attacks of vertigo. Each trial participant will be provided with the device and enough single-use electrode arrays to allow the array to be changed every 24 hours, for thirty days. Participants will be allowed to remove the sensor array for up to 60 minutes each day to allow them to wash and/or shower. If patients experience an episode of dizziness during the trial, they are required to log the details of the event in a trial diary. The identity of these days will not be revealed to the blinded investigator who will later conduct a formal, blinded analysis of the data. At the end of the thirty-day trial, the sensitivity and specificity of the device will be determined by assessing whether the data can be used to correctly identify the dates that participants reported dizziness. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE |
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Intervention ICMJE | Device: CAVA Device
The CAVA device will be worn continuously for thirty days, during which time it will record eye and head movements
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Study Arms ICMJE | Experimental: CAVA Dizziness Trial Arm
All trial participants are within this arm. All participants will wear the CAVA device for 30 days and follow the same procedures throughout the trial.
Intervention: Device: CAVA Device
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
35 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | October 31, 2021 | ||||||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Adults aged 18 and over.
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United Kingdom | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04026516 | ||||||||
Other Study ID Numbers ICMJE | 261099 (14-02-19) | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust | ||||||||
Study Sponsor ICMJE | Julie Dawson | ||||||||
Collaborators ICMJE | University of East Anglia | ||||||||
Investigators ICMJE |
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PRS Account | Norfolk and Norwich University Hospitals NHS Foundation Trust | ||||||||
Verification Date | October 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |