Trial Outcomes & Findings for Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Healthy Volunteer Trial (NCT NCT03661762)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

18 participants

Primary outcome timeframe

30 days

Results posted on

2020-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	18
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Volunteers n=18 Participants 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. CAVA: prototype device for monitoring dizziness
Age, Categorical <=18 years	0 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=18 Participants
Age, Categorical >=65 years	0 Participants n=18 Participants
Sex: Female, Male Female	12 Participants n=18 Participants
Sex: Female, Male Male	6 Participants n=18 Participants
Healthy Volunteers	18 Participants n=18 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=17 Participants 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.
Sensitivity and Specificity of a Computer Algorithm to Detect Artificially Induced Nystagmus Sensitivity	99.1 Percent
Sensitivity and Specificity of a Computer Algorithm to Detect Artificially Induced Nystagmus Specificity	98.6 Percent

SECONDARY outcome

Timeframe: 30 days

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Population: For the 30-day trial compliance, the number of participants differs as not all participants completed the trial in full.

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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=17 Participants 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.
Compliance With the Device. Daily compliance	82 percentage of participants
Compliance With the Device. 30-day compliance	100 percentage of participants

SECONDARY outcome

Timeframe: 30 days

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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=17 Participants 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.
Data Usefulness	0 Percentage of non-useful data Standard Deviation 0

SECONDARY outcome

Timeframe: 30 days

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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=17 Participants 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.
Data Usefulness	0 percentage of non-useful data

SECONDARY outcome

Timeframe: 30 days

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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=17 Participants 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.
Event Marker Functioning	100 percentage of button presses identified

SECONDARY outcome

Timeframe: 30 days

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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=17 Participants 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.
Time Stamp Accuracy	-17.49 minutes per day Standard Deviation 1.47

SECONDARY outcome

Timeframe: 30 days

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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=17 Participants 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.
Accelerometer Functioning Slow head turning	97 percentage of movements identified
Accelerometer Functioning Slow head nodding	100 percentage of movements identified
Accelerometer Functioning Fast head turning	93 percentage of movements identified
Accelerometer Functioning Fast head nodding	100 percentage of movements identified
Accelerometer Functioning Fast head tilting	97 percentage of movements identified
Accelerometer Functioning Slow head tilting	100 percentage of movements identified

SECONDARY outcome

Timeframe: 30 days

Population: Healthy volunteers

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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=17 Participants 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.
Data Drop-outs	4 Total number of drop outs

Adverse Events

Healthy Volunteers

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Healthy Volunteers n=18 participants at risk 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.
Skin and subcutaneous tissue disorders Over rubbed under left eye	5.6% 1/18 • Number of events 1 • 30 days
Skin and subcutaneous tissue disorders Erosion under all electrode sites	5.6% 1/18 • Number of events 1 • 30 days
Skin and subcutaneous tissue disorders Redness under electrodes	44.4% 8/18 • Number of events 8 • 30 days
Product Issues Disturbed sleep	5.6% 1/18 • Number of events 1 • 30 days
Respiratory, thoracic and mediastinal disorders Sore throat	5.6% 1/18 • Number of events 1 • 30 days
Skin and subcutaneous tissue disorders Allergic reaction	5.6% 1/18 • Number of events 1 • 30 days
Respiratory, thoracic and mediastinal disorders Swollen lymph nodes	5.6% 1/18 • Number of events 1 • 30 days

Additional Information

Mr John Phillips

Norfolk and Norwich University Hospitals NHS Foundation Trust

Phone: : +44 1603 593054

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place