CAVA: Dizziness Trial
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.
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.
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.