Dizziness
Conditions
Brief summary
The goal of this study is to test the consistency and repeatability of a portable goggle system for testing optokinetic, ocular, and reaction time. The study examines the day to day consistency, time of day and learning effects as well as any secondary motion sickness.
Detailed description
The goal of this study was to test the constancy and repeatability of this test by testing it in different individuals and different times of day, after a variety of tasks and after repeated performance
Interventions
DEVICEPAS Goggle
PAS goggle is a self-contained stimulus and sensing device that is designed to deliver the visual stimuli currently delivered via light projected on a wall while simultaneously recording the movement of the eyes. Each vestibular testing session last about 15 minutes.
Sponsors
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 to 65 * Both Females and males * Staff and students at all levels at the University of Miami or first-degree - relatives/significant others of those individuals.
Exclusion criteria
* History of vestibular disorder/dysfunction * Central processing disorder * Impaired vision without corrective lenses (max 20/60 uncorrected) * Moderate to severe hearing loss \[\>55 decibel (dB) Pure Tone Average (PTA), \<50% word identification\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vestibular Reaction Times | 2 Days | Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the following sub-tests: a) Visual Reactive Time (VRT), b) Saccades and Reaction Time (SRT) Saccade Latency, c) SRT Motor Latency, and d) Auditory Reaction Time (ART). ART, VRT and SRT subtests are all evaluated in msec. |
| Vestibular Subjective Visual Vertical | 2 Days | Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the Subjective Visual Vertical sub-test assessed in degrees. |
| Vestibular Smooth Pursuit Horizontal | 2 Days | Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the Smooth Pursuit Horizontal (SPH) sub-tests in degree squared per second. |
| Vestibular Percentage of Saccade | 2 Days | Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the sub-tests Smooth Pursuit Horizontal (SPH) evaluated as percentage of saccades completed. |
| Vestibular Anti-Saccade | 2 Days | Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the Anti-saccade sub-test evaluted in Percent Error. |
| Vestibular Gain | 2 Days | Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the following sub-tests: a) OKN at 60 degrees/second, and b) Smooth Percent Horizontal Velocity. Subtests are all evaluated in gain (output/input in decimal form) |
| Vestibular Saccade Horizontal | 2 Days | Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the Saccade Horizontal sub-tests evaluated in seconds. |
| Vestibular Predictive Saccade | 2 Days | Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the subtest Predictive Saccade (PS) evaluated as percentage of prediction. |
| Motion Sickness as Measured by the MSAQ | Day 1 | Motion sickness is measured by the subjects being given a motion sickness assessment questionnaire (MSAQ). The MSAQ is a validated measure of motion sickness and in this questionnaire the examiner asks subjects 16 questions. Subjects score each question as not at all (score of zero) or on a seventy scale of 1-9. The total score ranging from 0-144 with the score reported as a percentage. The higher percentage score indicates more motion symptoms experienced by the subjects. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Repeatability Group Healthy participants perform goggle testing on two consecutive days to determine if the testing results are repeatable. Testing will be between 10 am and 2 pm and testing on the two sessions will be within 30 minutes of the same time. Sessions can be on two consecutive days or separated by up to 4 days. | 12 |
| Time of Day Group Healthy participants perform goggle testing at two different times of day to determine if time of day affects goggle testing performance. One quarter of the participants in this arm will undergo one test at 8 am on the first session and 10 am on the second session. A second quarter will undergo the tests at 10 am on first session and 8 am on the second session. A third quarter will undergo one test at 3 pm on the first session and 10 am on the second session. The fourth quarter will undergo the tests at 10 am on first session and 3 pm on the second session. In all these cases the sessions can be on consecutive days or separated by up to 4 days. | 20 |
| Learning Affect Group Healthy participants perform goggle testing back to back on the same day to determine if performance on second test changes from first test suggesting a learning affect. | 21 |
| MSQ Group Healthy participants perform goggle testing and upon completion of each goggle testing session will complete a Motion Sickness Questionnaire (MSQ) to determine if they show any signs of motion sickness. | 1 |
| OKN Only Group OKN Only Group is for exploratory aims only. Healthy participants will undergo goggle testing limited to Optokinetic Nystagmus (OKN) recordings at two stimulus speeds (20 and 60 deg/s) in both the counterclockwise and clockwise directions. | 24 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 3 | 0 | 4 | 1 | 8 |
Baseline characteristics
| Characteristic | Repeatability Group | Time of Day Group | Learning Affect Group | MSQ Group | OKN Only Group | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 20 Participants | 21 Participants | 1 Participants | 24 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 20 Participants | 21 Participants | 1 Participants | 19 Participants | 72 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 20 Participants | 21 Participants | 0 Participants | 20 Participants | 72 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 11 Participants | 1 Participants | 4 Participants | 35 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 10 Participants | 0 Participants | 20 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 20 | 0 / 21 | 0 / 1 | 0 / 24 |
| other Total, other adverse events | 0 / 12 | 0 / 20 | 0 / 21 | 0 / 1 | 0 / 24 |
| serious Total, serious adverse events | 0 / 12 | 0 / 20 | 0 / 21 | 0 / 1 | 0 / 24 |
Outcome results
Primary
Motion Sickness as Measured by the MSAQ
Motion sickness is measured by the subjects being given a motion sickness assessment questionnaire (MSAQ). The MSAQ is a validated measure of motion sickness and in this questionnaire the examiner asks subjects 16 questions. Subjects score each question as not at all (score of zero) or on a seventy scale of 1-9. The total score ranging from 0-144 with the score reported as a percentage. The higher percentage score indicates more motion symptoms experienced by the subjects.
Time frame: Day 1
Population: Participants in the MSQ Groups were the only intended participants to be assessed for this outcome. No participants completed the study for this arm.
Primary
Vestibular Anti-Saccade
Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the Anti-saccade sub-test evaluted in Percent Error.
Time frame: 2 Days
Population: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Repeatability Group | Vestibular Anti-Saccade | Session 1 | 39.09 percentage of error | Standard Deviation 28.74 |
| Repeatability Group | Vestibular Anti-Saccade | Session 2 | 28.17 percentage of error | Standard Deviation 26.33 |
| Time of Day Group | Vestibular Anti-Saccade | Session 1 | 23.75 percentage of error | Standard Deviation 17.16 |
| Time of Day Group | Vestibular Anti-Saccade | Session 2 | 21.88 percentage of error | Standard Deviation 15.11 |
| Learning Affect Group | Vestibular Anti-Saccade | Session 1 | 34.56 percentage of error | Standard Deviation 24.42 |
| Learning Affect Group | Vestibular Anti-Saccade | Session 2 | 24.26 percentage of error | Standard Deviation 17.38 |
Primary
Vestibular Gain
Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the following sub-tests: a) OKN at 60 degrees/second, and b) Smooth Percent Horizontal Velocity. Subtests are all evaluated in gain (output/input in decimal form)
Time frame: 2 Days
Population: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Repeatability Group | Vestibular Gain | OKN Session 1 | 0.74 ratio | Standard Deviation 0.09 |
| Repeatability Group | Vestibular Gain | OKN Session 2 | 0.72 ratio | Standard Deviation 0.11 |
| Repeatability Group | Vestibular Gain | SPH Session 1 | 0.98 ratio | Standard Deviation 0.04 |
| Repeatability Group | Vestibular Gain | SPH Session 2 | 0.99 ratio | Standard Deviation 0.04 |
| Time of Day Group | Vestibular Gain | SPH Session 2 | 0.98 ratio | Standard Deviation 0.08 |
| Time of Day Group | Vestibular Gain | OKN Session 1 | 0.78 ratio | Standard Deviation 0.09 |
| Time of Day Group | Vestibular Gain | SPH Session 1 | 0.74 ratio | Standard Deviation 0.13 |
| Time of Day Group | Vestibular Gain | OKN Session 2 | 0.97 ratio | Standard Deviation 0.07 |
| Learning Affect Group | Vestibular Gain | SPH Session 2 | 0.95 ratio | Standard Deviation 0.09 |
| Learning Affect Group | Vestibular Gain | OKN Session 2 | 0.77 ratio | Standard Deviation 0.1 |
| Learning Affect Group | Vestibular Gain | SPH Session 1 | 0.96 ratio | Standard Deviation 0.06 |
| Learning Affect Group | Vestibular Gain | OKN Session 1 | 0.79 ratio | Standard Deviation 0.09 |
Primary
Vestibular Percentage of Saccade
Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the sub-tests Smooth Pursuit Horizontal (SPH) evaluated as percentage of saccades completed.
Time frame: 2 Days
Population: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Repeatability Group | Vestibular Percentage of Saccade | SPH Session 1 | 12.83 percentage | Standard Deviation 12.14 |
| Repeatability Group | Vestibular Percentage of Saccade | SPH Session 2 | 12.72 percentage | Standard Deviation 5.79 |
| Time of Day Group | Vestibular Percentage of Saccade | SPH Session 1 | 16.49 percentage | Standard Deviation 9.8 |
| Time of Day Group | Vestibular Percentage of Saccade | SPH Session 2 | 14.38 percentage | Standard Deviation 8.38 |
| Learning Affect Group | Vestibular Percentage of Saccade | SPH Session 1 | 21.23 percentage | Standard Deviation 13.7 |
| Learning Affect Group | Vestibular Percentage of Saccade | SPH Session 2 | 18.23 percentage | Standard Deviation 9.43 |
Primary
Vestibular Predictive Saccade
Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the subtest Predictive Saccade (PS) evaluated as percentage of prediction.
Time frame: 2 Days
Population: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Repeatability Group | Vestibular Predictive Saccade | PS Session 1 | 37.04 percentage of prediction | Standard Deviation 18.21 |
| Repeatability Group | Vestibular Predictive Saccade | PS Session 2 | 32.66 percentage of prediction | Standard Deviation 21.34 |
| Time of Day Group | Vestibular Predictive Saccade | PS Session 1 | 36.52 percentage of prediction | Standard Deviation 21.99 |
| Time of Day Group | Vestibular Predictive Saccade | PS Session 2 | 27.50 percentage of prediction | Standard Deviation 20.79 |
| Learning Affect Group | Vestibular Predictive Saccade | PS Session 1 | 35.88 percentage of prediction | Standard Deviation 18.94 |
| Learning Affect Group | Vestibular Predictive Saccade | PS Session 2 | 35.12 percentage of prediction | Standard Deviation 24.51 |
Primary
Vestibular Reaction Times
Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the following sub-tests: a) Visual Reactive Time (VRT), b) Saccades and Reaction Time (SRT) Saccade Latency, c) SRT Motor Latency, and d) Auditory Reaction Time (ART). ART, VRT and SRT subtests are all evaluated in msec.
Time frame: 2 Days
Population: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Repeatability Group | Vestibular Reaction Times | ART Session 1 | 240.89 msec | Standard Deviation 61.81 |
| Repeatability Group | Vestibular Reaction Times | ART Session 2 | 228.95 msec | Standard Deviation 59.15 |
| Repeatability Group | Vestibular Reaction Times | VRT Session 1 | 237.14 msec | Standard Deviation 47.89 |
| Repeatability Group | Vestibular Reaction Times | VRT Session 2 | 229.52 msec | Standard Deviation 53.53 |
| Repeatability Group | Vestibular Reaction Times | SRT Motor Latency Session 1 | 0.53 msec | Standard Deviation 0.11 |
| Repeatability Group | Vestibular Reaction Times | SRT Motor Latency Session 2 | 0.49 msec | Standard Deviation 0.11 |
| Repeatability Group | Vestibular Reaction Times | SRT Saccade Latency Session 1 | 0.20 msec | Standard Deviation 0.04 |
| Repeatability Group | Vestibular Reaction Times | SRT Saccade Latency Session 2 | 0.18 msec | Standard Deviation 0.03 |
| Time of Day Group | Vestibular Reaction Times | VRT Session 1 | 212.21 msec | Standard Deviation 26.38 |
| Time of Day Group | Vestibular Reaction Times | SRT Saccade Latency Session 1 | 0.18 msec | Standard Deviation 0.03 |
| Time of Day Group | Vestibular Reaction Times | VRT Session 2 | 218.34 msec | Standard Deviation 30.73 |
| Time of Day Group | Vestibular Reaction Times | SRT Motor Latency Session 1 | 0.41 msec | Standard Deviation 0.11 |
| Time of Day Group | Vestibular Reaction Times | SRT Motor Latency Session 2 | 0.38 msec | Standard Deviation 0.11 |
| Time of Day Group | Vestibular Reaction Times | ART Session 1 | 202.96 msec | Standard Deviation 41.43 |
| Time of Day Group | Vestibular Reaction Times | ART Session 2 | 202.27 msec | Standard Deviation 57.42 |
| Time of Day Group | Vestibular Reaction Times | SRT Saccade Latency Session 2 | 0.19 msec | Standard Deviation 0.03 |
| Learning Affect Group | Vestibular Reaction Times | VRT Session 1 | 224.74 msec | Standard Deviation 42.22 |
| Learning Affect Group | Vestibular Reaction Times | ART Session 2 | 213.07 msec | Standard Deviation 53.63 |
| Learning Affect Group | Vestibular Reaction Times | ART Session 1 | 233.09 msec | Standard Deviation 65.7 |
| Learning Affect Group | Vestibular Reaction Times | VRT Session 2 | 230.63 msec | Standard Deviation 48.68 |
| Learning Affect Group | Vestibular Reaction Times | SRT Saccade Latency Session 1 | 0.20 msec | Standard Deviation 0.06 |
| Learning Affect Group | Vestibular Reaction Times | SRT Motor Latency Session 2 | 0.44 msec | Standard Deviation 0.13 |
| Learning Affect Group | Vestibular Reaction Times | SRT Motor Latency Session 1 | 0.44 msec | Standard Deviation 0.14 |
| Learning Affect Group | Vestibular Reaction Times | SRT Saccade Latency Session 2 | 0.20 msec | Standard Deviation 0.05 |
Primary
Vestibular Saccade Horizontal
Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the Saccade Horizontal sub-tests evaluated in seconds.
Time frame: 2 Days
Population: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Repeatability Group | Vestibular Saccade Horizontal | Session 1 | 0.17 seconds | Standard Deviation 0.03 |
| Repeatability Group | Vestibular Saccade Horizontal | Session 2 | 0.18 seconds | Standard Deviation 0.03 |
| Time of Day Group | Vestibular Saccade Horizontal | Session 1 | 0.18 seconds | Standard Deviation 0.02 |
| Time of Day Group | Vestibular Saccade Horizontal | Session 2 | 0.18 seconds | Standard Deviation 0.02 |
| Learning Affect Group | Vestibular Saccade Horizontal | Session 1 | 0.18 seconds | Standard Deviation 0.02 |
| Learning Affect Group | Vestibular Saccade Horizontal | Session 2 | 0.18 seconds | Standard Deviation 0.03 |
Primary
Vestibular Smooth Pursuit Horizontal
Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the Smooth Pursuit Horizontal (SPH) sub-tests in degree squared per second.
Time frame: 2 Days
Population: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Repeatability Group | Vestibular Smooth Pursuit Horizontal | Session 1 | 10006 degree squared per second | Standard Deviation 815 |
| Repeatability Group | Vestibular Smooth Pursuit Horizontal | Session 2 | 9986 degree squared per second | Standard Deviation 754 |
| Time of Day Group | Vestibular Smooth Pursuit Horizontal | Session 1 | 10739 degree squared per second | Standard Deviation 849 |
| Time of Day Group | Vestibular Smooth Pursuit Horizontal | Session 2 | 10450 degree squared per second | Standard Deviation 818 |
| Learning Affect Group | Vestibular Smooth Pursuit Horizontal | Session 1 | 10303 degree squared per second | Standard Deviation 905 |
| Learning Affect Group | Vestibular Smooth Pursuit Horizontal | Session 2 | 10219 degree squared per second | Standard Deviation 1009 |
Primary
Vestibular Subjective Visual Vertical
Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the Subjective Visual Vertical sub-test assessed in degrees.
Time frame: 2 Days
Population: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Repeatability Group | Vestibular Subjective Visual Vertical | Session 1 | 2.08 degrees | Standard Deviation 1.61 |
| Repeatability Group | Vestibular Subjective Visual Vertical | Session 2 | 1.52 degrees | Standard Deviation 1.81 |
| Time of Day Group | Vestibular Subjective Visual Vertical | Session 1 | 2.04 degrees | Standard Deviation 2.36 |
| Time of Day Group | Vestibular Subjective Visual Vertical | Session 2 | 1.52 degrees | Standard Deviation 2.17 |
| Learning Affect Group | Vestibular Subjective Visual Vertical | Session 1 | 1.21 degrees | Standard Deviation 2.02 |
| Learning Affect Group | Vestibular Subjective Visual Vertical | Session 2 | 1.64 degrees | Standard Deviation 1.87 |