CAVA: Dizziness Trial (CAVA)

December 18, 2023 updated by: Julie Dawson

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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
30 days
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.
30 days
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.
30 days
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.
30 days
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).
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Julie Dawson

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of East Anglia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Phillips, Consultant, Dr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Benign Paroxysmal Positional Vertigo

Clinical Trials on CAVA Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings