Optokinetic NystagmusCAVANCT03661762
Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Healthy Volunteer Trial
An observational study of Optokinetic Nystagmus, run by Julie Dawson at 1 site in United Kingdom.
Trial summary
Clinical investigation of a medical device (CAVA) for recording eye movements. Healthy volunteers will wear the device for 23 hours a day, for 30 days. On 8 separate days of the trial they will induce optokinetic nystagmus (a normal reflex in response to full-field motion) by watching a short video of less than 1… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optokinetic Nystagmus
- What is being tested?
- CAVA
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Aug 2018to 5 Apr 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers, aged 18 or over.
Who may be able to join
- Adults aged 18 and over
- Able to commit to 30 days of continuous wear of the trial device as per the study plan
- Own a telephone
Who cannot join
- Potential participants who have a history of dermatological disease or damage around the forehead
- Potential participants who have an allergy to plasters and/or medical adhesives
- History of dizziness, vertigo, balance disorders, or syncope
- 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
- Unable to follow the testing protocol
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
Clinical investigation of a medical device (CAVA) for recording eye movements. Healthy volunteers will wear the device for 23 hours a day, for 30 days. On 8 separate days of the trial they will induce optokinetic nystagmus (a normal reflex in response to full-field motion) by watching a short video of less than 1 minute in duration. The data will be analysed offline by a scientist, who will attempt to identify the dates that the nystagmus was induced.
Read the detailed description
Dizziness is a common condition that is responsible for a significant degree of material morbidity and burden on the National 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 small group of volunteers. The results showed that their device is capable of accurately, precisely and reliably identifying periods of dizziness over a short period of time. Independent market research has confirmed that their device could meet the required clinical need, would be desired by clinicians, and that there is no equivalent solution currently available. The investigators have received an award from the Medical Research Council to trial their device in a large cohort of healthy volunteers. Once completed, they will be positioned well to test their device in a cohort of patients with a defined dizziness syndrome, before further testing their device in a more diverse patient population. Once validated, developed and brought to market, the device would provide early diagnosis and accurate treatment for a significant proportion of the patient population. This would save the National Health Service money by reducing multiple visits to General Practitioner clinics, reducing referrals to multiple specialist clinics, and reducing treatment required from falls and other conditions associated with dizziness.
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. 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 will be able to capture any occurrence, of a minimum period of thirty seconds, of artificially induced nystagmus, within a 24-hour period of time. Each 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. On eight of the thirty days for which they wear the array, each participant will be required to induce physiological nystagmus by viewing optokinetic video footage. The footage will be viewed on a portable screen (of a deactivated mobile phone) inside a Virtual Reality headset. These will be issued to the participants at the beginning of the trial. Participants will undertake the procedure whilst stationary for the first four days, and whilst walking gently on the spot for the remaining four days. The identity of these days will not be revealed to the blinded investigator who will later analyse 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 induced nystagmus.
- Conditions
- Optokinetic Nystagmus
- Being tested
- CAVA
- Keywords
- eye movements, electronystagmography, nystagmus, electrooculogram, vestibular assessment
- Medical subject headings
- Nystagmus, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAVADevice
prototype device for monitoring dizziness
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | All trial participants are within this group. All trial participants will wear the CAVA device for up to 23 hours a day, for 30 days. Receives: Device: CAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of a Computer Algorithm to Detect Artificially Induced Nystagmus
Dates containing nystagmus. Of the ~450 days' worth of data captured during the study, 120 will contain artificially induced nystagmus. A computer algorithm has been developed at the University of East Anglia for detecting nystagmus. The key measurements are the sensitivity and specificity of the algorithm's results when applied to data captured during the trial. This measurement will be assessed post-trial.
Measured: 30 days
Secondary outcomes (14)
Post-trial Participant Questionnaire.
A 2-page questionnaire producing qualitative and quantitative data. Participants rate different aspects of their experiences with the device using a sliding scale and have the opportunity to write more detailed descriptions.
Measured: 30 days
Compliance With the Device.
1 - There is a minimum of 80% compliance with wearing the device for each single day of the trial for a minimum of 80% of participants. 2 There is a minimum of 80% compliance with wearing the device for the entirety of the 30-day trial for a minimum of 80% of participants.
Measured: 30 days
Data Usefulness
The device provides less than 5% non-useful data for each participant. We will report the percentage of non-useful data (corrupted or flat-line data) that is captured for each participant.
Measured: 30 days
Data Usefulness
The device provides less than 5% non-useful data for the entirety of the 30-day trial across all participants. We will report the percentage of non-useful data (corrupted or flat-line data) that is captured over the entire trial, across all participants.
Measured: 30 days
Event Marker Functioning
During a return visit, the event marker on each device will be pressed and the time noted. Post-trial, the data on the device will be examined to confirm that an event was recorded on the correct date. This will produce either a positive or negative outcome, depending on whether the event marker button press is present in the data or not. The percentage of identifiable button presses across all devices will be reported.
Measured: 30 days
Time Stamp Accuracy
The difference will be calculated between the time noted by the research team and the time logged by the device when the event marker was activated. The time difference (in hh:mm:ss) will be calculated across all devices and we will report the average and standard deviation of the clock drift.
Measured: 30 days
Accelerometer Functioning
Participants will perform a number of head movements and the device data will be examined visually to confirm that they can be identified. This will produce either a positive or negative outcome for each head movement, depending on whether the movement is visible in the data or not. The proportion of successfully identified head movements will be reported.
Measured: 30 days
Accuracy of Nystagmus Beat Direction
Participants will undergo caloric testing at the end of the trial, during which they will wear conventional Videonystagmography (VNG) goggles as well as the CAVA device. The beat direction (whether the fast phase of the nystagmus is towards the left or right ear) will be determined from both sources of data during the period of nystagmus captured. This will produce either a positive or negative outcome, depending on whether the beat direction matches in both data sources. The proportion of matches will be reported.
Measured: 1 hour
Accuracy of Nystagmus Onset Time
Also from the data captured during caloric testing, the start time of nystagmus will be identified from both the VNG data and data captured by the CAVA device. The time difference (in mm:ss) will be calculated between the two data sources and the mean time difference will be reported.
Measured: 1 hour
Accuracy of Nystagmus Finishing Time
Also from the data captured during caloric testing, the finishing time of nystagmus will be identified from both the VNG data and data captured by the CAVA device. The time difference (in mm:ss) will be calculated between the two data sources and the mean time difference will be reported.
Measured: 1 hour
Accuracy of Nystagmus Peak Time
Also from the data captured during caloric testing, the time at which the nystagmus reaches its maximum slow phase velocity will be calculated from the VNG data and the data captured by the CAVA device. The time difference (in mm:ss) will be calculated between the two data sources and the mean time difference will be reported.
Measured: 1 hour
Accuracy of Nystagmus Frequency
Also from the data captured during caloric testing, the number of beats will be counted during the period identified as the nystagmus peak time. This will be calculated for both the VNG data and the data captured by the CAVA device. From the number of beats and time duration examined, the frequency of the nystagmus will be determined. The difference between the two systems will be calculated and the mean difference will be reported. The Unit of Measure will be Hz (number of beats per second).
Measured: 1 hour
Data Drop-outs
The device provides less 5 drop-outs for each single day of the trial for each participant. We will report the maximum number of drop-outs (periods when the device stopped logging) per participant, per day.
Measured: 30 days
Data Drop-outs
The device provides less 60 drop-outs for the entirety of the 30-day trial across all participants. We will report the total number of drop-outs that occurred over the entire trial, across all participants.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start23 Aug 2018
- Primary completion12 Dec 2018
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Optokinetic NystagmusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Dawson
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia, Medical Research Council
- Responsible party
- Sponsor-investigator, Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust
- Investigators
- John Phillips, Consultant, Principal investigator, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661762
- Sponsor's protocol ID
- 240847 (28-02-18)
- Acronym
- CAVA
- Status last verified
- Nov 2020
- First submitted
- 26 Jul 2018
- Last updated
- 10 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Healthy Volunteer Trial
- ClinicalTrials.gov ID
- NCT03661762
- Acronym / sponsor ID
- CAVA / 240847 (28-02-18)
- Conditions
- Optokinetic Nystagmus
- Keywords
- eye movements, electronystagmography, nystagmus, electrooculogram, vestibular assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Julie DawsonUniversity, hospital or other
- Collaborators
- University of East Anglia, Medical Research Council
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Posted 10 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical investigation of a medical device (CAVA) for recording eye movements. Healthy volunteers will wear the device for 23 hours a day, for 30 days. On 8 separate days of the trial they will induce optokinetic nystagmus (a normal reflex in response to full-field motion) by watching a short video of less than 1 minute in duration. The data will be analysed offline by a scientist, who will attempt to identify the dates that the nystagmus was induced.
Detailed description
Dizziness is a common condition that is responsible for a significant degree of material morbidity and burden on the National 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 small group of volunteers. The results showed that their device is capable of accurately, precisely and reliably identifying periods of dizziness over a short period of time. Independent market research has confirmed that their device could meet the required clinical need, would be desired by clinicians, and that there is no equivalent solution currently available. The investigators have received an award from the Medical Research Council to trial their device in a large cohort of healthy volunteers. Once completed, they will be positioned well to test their device in a cohort of patients with a defined dizziness syndrome, before further testing their device in a more diverse patient population. Once validated, developed and brought to market, the device would provide early diagnosis and accurate treatment for a significant proportion of the patient population. This would save the National Health Service money by reducing multiple visits to General Practitioner clinics, reducing referrals to multiple specialist clinics, and reducing treatment required from falls and other conditions associated with dizziness.
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. 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 will be able to capture any occurrence, of a minimum period of thirty seconds, of artificially induced nystagmus, within a 24-hour period of time. Each 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. On eight of the thirty days for which they wear the array, each participant will be required to induce physiological nystagmus by viewing optokinetic video footage. The footage will be viewed on a portable screen (of a deactivated mobile phone) inside a Virtual Reality headset. These will be issued to the participants at the beginning of the trial. Participants will undertake the procedure whilst stationary for the first four days, and whilst walking gently on the spot for the remaining four days. The identity of these days will not be revealed to the blinded investigator who will later analyse 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 induced nystagmus.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: CAVAAll trial participants are within this group. All trial participants will wear the CAVA device for up to 23 hours a day, for 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers, aged 18 or over.
Key inclusion criteria (3 listed)
- Adults aged 18 and over
- Able to commit to 30 days of continuous wear of the trial device as per the study plan
- Own a telephone
Key exclusion criteria (8 listed)
- Potential participants who have a history of dermatological disease or damage around the forehead
- Potential participants who have an allergy to plasters and/or medical adhesives
- History of dizziness, vertigo, balance disorders, or syncope
- History of hypertension or cardiac problems (uncontrolled, acute or de-compensated phase)
- History of ear disease, or previous ear surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAVAprototype device for monitoring dizziness | Device | Healthy Volunteers |
Primary outcome
Sensitivity and Specificity of a Computer Algorithm to Detect Artificially Induced Nystagmus
Time frame: 30 days
Dates containing nystagmus. Of the ~450 days' worth of data captured during the study, 120 will contain artificially induced nystagmus. A computer algorithm has been developed at the University of East Anglia for detecting nystagmus. The key measurements are the sensitivity and specificity of the algorithm's results when applied to data captured during the trial. This measurement will be assessed post-trial.
14 secondary outcomes
Post-trial Participant Questionnaire.
Time frame: 30 days
Compliance With the Device.
Time frame: 30 days
Data Usefulness
Time frame: 30 days
Data Usefulness
Time frame: 30 days
Event Marker Functioning
Time frame: 30 days
Time Stamp Accuracy
Time frame: 30 days
Accelerometer Functioning
Time frame: 30 days
Accuracy of Nystagmus Beat Direction
Time frame: 1 hour
Accuracy of Nystagmus Onset Time
Time frame: 1 hour
Accuracy of Nystagmus Finishing Time
Time frame: 1 hour
Accuracy of Nystagmus Peak Time
Time frame: 1 hour
Accuracy of Nystagmus Frequency
Time frame: 1 hour
Data Drop-outs
Time frame: 30 days
Data Drop-outs
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Phillips, Consultant principal investigator
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optokinetic Nystagmus, run by Julie Dawson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of a Computer Algorithm to Detect Artificially Induced Nystagmus (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.