CAVA: Dizziness Trial (CAVA)

Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Dizziness Trial

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.

Study Overview

• Status: Suspended
• Conditions: Benign Paroxysmal Positional Vertigo; Vestibular Migraine; Meniere's Disease; Recurrent Vestibulopathy
• Intervention / Treatment: Device: CAVA Device

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Phillips, Consultant; Phone Number: +44 1603 593054; Email: john.phillips@mac.com
• Study Contact Backup: Name: Jacob Newman, Dr; Phone Number: +44 1603 593054; Email: jacob.newman@uea.ac.uk

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Norfolk & Norwich University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Julie Dawson
• Collaborators: University of East Anglia
• Investigators: Principal Investigator: John Phillips, Consultant, Dr

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: nystagmus; eye movements; electrooculogram; Electronystagmograpy; vestibular assessment; ambulatory monitoring
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Cranial Nerve Diseases; Vestibular Diseases; Sensation Disorders; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Endolymphatic Hydrops; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness; Vestibular Neuronitis; Meniere Disease
• Other Study ID Numbers: 261099 (14-02-19)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No