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CAVA: Dizziness Trial (CAVA)

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ClinicalTrials.gov Identifier: NCT04026516
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
University of East Anglia
Information provided by (Responsible Party):
Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Meniere's Disease Benign Paroxysmal Positional Vertigo Recurrent Vestibulopathy Vestibular Migraine Device: CAVA Device Not Applicable

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 : 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.
Device: CAVA Device
The CAVA device will be worn continuously for thirty days, during which time it will record eye and head movements




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Post-trial participant questionnaire [ Time Frame: 30 days ]
    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.

  2. Compliance with wearing the device [ Time Frame: 30 days ]
    Investigators will check the participants compliance of wearing the device by using the data in the participants' trial diaries.

  3. Functionality of the device's accelerometer [ Time Frame: 30 days ]
    Data will be downloaded from the device and manually checked to ensure that valid data has been captured.

  4. Functionality of the device's event marker [ Time Frame: 30 days ]
    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.

  5. Functionality of the device's timestamping capabilities [ Time Frame: 30 days ]
    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).



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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:

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.

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): NCT04026516


Contacts
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Contact: John Phillips, Consultant +44 1603 593054 john.phillips@mac.com
Contact: Jacob Newman, Dr +44 1603 593054 jacob.newman@uea.ac.uk

Locations
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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   
Sponsors and Collaborators
Julie Dawson
University of East Anglia
Investigators
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Principal Investigator: John Phillips, Consultant Dr
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Responsible Party: Julie Dawson, Research Services Manager, Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04026516    
Other Study ID Numbers: 261099 (14-02-19)
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust:
eye movements
Electronystagmograpy
nystagmus
electrooculogram
vestibular assessment
ambulatory monitoring
Additional relevant MeSH terms:
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Vertigo
Benign Paroxysmal Positional Vertigo
Dizziness
Meniere Disease
Vestibular Neuronitis
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Sensation Disorders
Endolymphatic Hydrops
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Cranial Nerve Diseases