Trial Outcomes & Findings for Vestibular Testing: Consistency and Effects Over Time (NCT NCT03182868)
NCT ID: NCT03182868
Last Updated: 2022-05-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
2 Days
Results posted on
2022-05-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
20
|
21
|
1
|
24
|
|
Overall Study
COMPLETED
|
9
|
20
|
17
|
0
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
4
|
1
|
8
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
0
|
4
|
1
|
8
|
Baseline Characteristics
Vestibular Testing: Consistency and Effects Over Time
Baseline characteristics by cohort
| Measure |
Repeatability Group
n=12 Participants
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.
|
Time of Day Group
n=20 Participants
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.
|
Learning Affect Group
n=21 Participants
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.
|
MSQ Group
n=1 Participants
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.
|
OKN Only Group
n=24 Participants
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.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
78 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
35 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
43 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
72 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
72 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 2 DaysPopulation: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
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.
Outcome measures
| Measure |
Repeatability Group
n=9 Participants
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.
|
Time of Day Group
n=20 Participants
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.
|
Learning Affect Group
n=17 Participants
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.
|
|---|---|---|---|
|
Vestibular Reaction Times
ART Session 2
|
228.95 msec
Standard Deviation 59.15
|
202.27 msec
Standard Deviation 57.42
|
213.07 msec
Standard Deviation 53.63
|
|
Vestibular Reaction Times
VRT Session 2
|
229.52 msec
Standard Deviation 53.53
|
218.34 msec
Standard Deviation 30.73
|
230.63 msec
Standard Deviation 48.68
|
|
Vestibular Reaction Times
SRT Motor Latency Session 1
|
0.53 msec
Standard Deviation 0.11
|
0.41 msec
Standard Deviation 0.11
|
0.44 msec
Standard Deviation 0.14
|
|
Vestibular Reaction Times
SRT Saccade Latency Session 2
|
0.18 msec
Standard Deviation 0.03
|
0.19 msec
Standard Deviation 0.03
|
0.20 msec
Standard Deviation 0.05
|
|
Vestibular Reaction Times
ART Session 1
|
240.89 msec
Standard Deviation 61.81
|
202.96 msec
Standard Deviation 41.43
|
233.09 msec
Standard Deviation 65.70
|
|
Vestibular Reaction Times
VRT Session 1
|
237.14 msec
Standard Deviation 47.89
|
212.21 msec
Standard Deviation 26.38
|
224.74 msec
Standard Deviation 42.22
|
|
Vestibular Reaction Times
SRT Motor Latency Session 2
|
0.49 msec
Standard Deviation 0.11
|
0.38 msec
Standard Deviation 0.11
|
0.44 msec
Standard Deviation 0.13
|
|
Vestibular Reaction Times
SRT Saccade Latency Session 1
|
0.20 msec
Standard Deviation 0.04
|
0.18 msec
Standard Deviation 0.03
|
0.20 msec
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: 2 DaysPopulation: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
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.
Outcome measures
| Measure |
Repeatability Group
n=9 Participants
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.
|
Time of Day Group
n=20 Participants
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.
|
Learning Affect Group
n=17 Participants
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.
|
|---|---|---|---|
|
Vestibular Subjective Visual Vertical
Session 2
|
1.52 degrees
Standard Deviation 1.81
|
1.52 degrees
Standard Deviation 2.17
|
1.64 degrees
Standard Deviation 1.87
|
|
Vestibular Subjective Visual Vertical
Session 1
|
2.08 degrees
Standard Deviation 1.61
|
2.04 degrees
Standard Deviation 2.36
|
1.21 degrees
Standard Deviation 2.02
|
PRIMARY outcome
Timeframe: 2 DaysPopulation: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
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.
Outcome measures
| Measure |
Repeatability Group
n=9 Participants
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.
|
Time of Day Group
n=20 Participants
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.
|
Learning Affect Group
n=17 Participants
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.
|
|---|---|---|---|
|
Vestibular Smooth Pursuit Horizontal
Session 1
|
10006 degree squared per second
Standard Deviation 815
|
10739 degree squared per second
Standard Deviation 849
|
10303 degree squared per second
Standard Deviation 905
|
|
Vestibular Smooth Pursuit Horizontal
Session 2
|
9986 degree squared per second
Standard Deviation 754
|
10450 degree squared per second
Standard Deviation 818
|
10219 degree squared per second
Standard Deviation 1009
|
PRIMARY outcome
Timeframe: 2 DaysPopulation: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
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.
Outcome measures
| Measure |
Repeatability Group
n=9 Participants
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.
|
Time of Day Group
n=20 Participants
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.
|
Learning Affect Group
n=17 Participants
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.
|
|---|---|---|---|
|
Vestibular Percentage of Saccade
SPH Session 1
|
12.83 percentage
Standard Deviation 12.14
|
16.49 percentage
Standard Deviation 9.80
|
21.23 percentage
Standard Deviation 13.70
|
|
Vestibular Percentage of Saccade
SPH Session 2
|
12.72 percentage
Standard Deviation 5.79
|
14.38 percentage
Standard Deviation 8.38
|
18.23 percentage
Standard Deviation 9.43
|
PRIMARY outcome
Timeframe: 2 DaysPopulation: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
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.
Outcome measures
| Measure |
Repeatability Group
n=9 Participants
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.
|
Time of Day Group
n=20 Participants
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.
|
Learning Affect Group
n=17 Participants
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.
|
|---|---|---|---|
|
Vestibular Anti-Saccade
Session 1
|
39.09 percentage of error
Standard Deviation 28.74
|
23.75 percentage of error
Standard Deviation 17.16
|
34.56 percentage of error
Standard Deviation 24.42
|
|
Vestibular Anti-Saccade
Session 2
|
28.17 percentage of error
Standard Deviation 26.33
|
21.88 percentage of error
Standard Deviation 15.11
|
24.26 percentage of error
Standard Deviation 17.38
|
PRIMARY outcome
Timeframe: 2 DaysPopulation: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
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)
Outcome measures
| Measure |
Repeatability Group
n=9 Participants
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.
|
Time of Day Group
n=20 Participants
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.
|
Learning Affect Group
n=17 Participants
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.
|
|---|---|---|---|
|
Vestibular Gain
SPH Session 1
|
0.98 ratio
Standard Deviation 0.04
|
0.74 ratio
Standard Deviation 0.13
|
0.96 ratio
Standard Deviation 0.06
|
|
Vestibular Gain
OKN Session 1
|
0.74 ratio
Standard Deviation 0.09
|
0.78 ratio
Standard Deviation 0.09
|
0.79 ratio
Standard Deviation 0.09
|
|
Vestibular Gain
OKN Session 2
|
0.72 ratio
Standard Deviation 0.11
|
0.97 ratio
Standard Deviation 0.07
|
0.77 ratio
Standard Deviation 0.10
|
|
Vestibular Gain
SPH Session 2
|
0.99 ratio
Standard Deviation 0.04
|
0.98 ratio
Standard Deviation 0.08
|
0.95 ratio
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: 2 DaysPopulation: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
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.
Outcome measures
| Measure |
Repeatability Group
n=9 Participants
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.
|
Time of Day Group
n=20 Participants
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.
|
Learning Affect Group
n=17 Participants
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.
|
|---|---|---|---|
|
Vestibular Saccade Horizontal
Session 1
|
0.17 seconds
Standard Deviation 0.03
|
0.18 seconds
Standard Deviation 0.02
|
0.18 seconds
Standard Deviation 0.02
|
|
Vestibular Saccade Horizontal
Session 2
|
0.18 seconds
Standard Deviation 0.03
|
0.18 seconds
Standard Deviation 0.02
|
0.18 seconds
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: 2 DaysPopulation: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.
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.
Outcome measures
| Measure |
Repeatability Group
n=9 Participants
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.
|
Time of Day Group
n=20 Participants
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.
|
Learning Affect Group
n=17 Participants
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.
|
|---|---|---|---|
|
Vestibular Predictive Saccade
PS Session 1
|
37.04 percentage of prediction
Standard Deviation 18.21
|
36.52 percentage of prediction
Standard Deviation 21.99
|
35.88 percentage of prediction
Standard Deviation 18.94
|
|
Vestibular Predictive Saccade
PS Session 2
|
32.66 percentage of prediction
Standard Deviation 21.34
|
27.50 percentage of prediction
Standard Deviation 20.79
|
35.12 percentage of prediction
Standard Deviation 24.51
|
PRIMARY outcome
Timeframe: Day 1Population: Participants in the MSQ Groups were the only intended participants to be assessed for this outcome. No participants completed the study for this arm.
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.
Outcome measures
Outcome data not reported
Adverse Events
Repeatability Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Time of Day Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Learning Affect Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MSQ Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
OKN Only Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place