CAVA: Dizziness Trial

NCT ID: NCT04026516

Last Updated: 2023-12-22

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2025-05-31

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.

Conditions

Meniere's Disease; Benign Paroxysmal Positional Vertigo; Recurrent Vestibulopathy; Vestibular Migraine

Keywords

eye movements; Electronystagmograpy; nystagmus; electrooculogram; vestibular assessment; ambulatory monitoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CAVA Device

Intervention Type: DEVICE

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

Interventions

CAVA Device

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of East Anglia

OTHER

Sponsor Role: collaborator

Julie Dawson

OTHER

Sponsor Role: lead

Responsible Party

Julie Dawson

Research Services Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Phillips, Consultant

Role: PRINCIPAL_INVESTIGATOR

Dr

Locations

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, United Kingdom

Countries

United Kingdom

Other Identifiers

261099 (14-02-19)

Identifier Type: -

Identifier Source: org_study_id