Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-22 @ 2:04 PM
Study NCT ID:
NCT03182868
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2017-06-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vestibular Testing: Consistency and Effects Over Time
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004244', 'term': 'Dizziness'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.hoffer@miami.edu', 'phone': '305 243-1484', 'title': 'Michael Hoffer', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 2 days', 'eventGroups': [{'id': 'EG000', 'title': 'Repeatability Group', 'description': '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.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Time of Day Group', 'description': '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.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Learning Affect Group', 'description': '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.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MSQ Group', 'description': '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.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'OKN Only Group', 'description': '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.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Vestibular Reaction Times', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Repeatability Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Time of Day Group', 'description': '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.'}, {'id': 'OG002', 'title': 'Learning Affect Group', 'description': '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.'}], 'classes': [{'title': 'ART Session 1', 'categories': [{'measurements': [{'value': '240.89', 'spread': '61.81', 'groupId': 'OG000'}, {'value': '202.96', 'spread': '41.43', 'groupId': 'OG001'}, {'value': '233.09', 'spread': '65.70', 'groupId': 'OG002'}]}]}, {'title': 'ART Session 2', 'categories': [{'measurements': [{'value': '228.95', 'spread': '59.15', 'groupId': 'OG000'}, {'value': '202.27', 'spread': '57.42', 'groupId': 'OG001'}, {'value': '213.07', 'spread': '53.63', 'groupId': 'OG002'}]}]}, {'title': 'VRT Session 1', 'categories': [{'measurements': [{'value': '237.14', 'spread': '47.89', 'groupId': 'OG000'}, {'value': '212.21', 'spread': '26.38', 'groupId': 'OG001'}, {'value': '224.74', 'spread': '42.22', 'groupId': 'OG002'}]}]}, {'title': 'VRT Session 2', 'categories': [{'measurements': [{'value': '229.52', 'spread': '53.53', 'groupId': 'OG000'}, {'value': '218.34', 'spread': '30.73', 'groupId': 'OG001'}, {'value': '230.63', 'spread': '48.68', 'groupId': 'OG002'}]}]}, {'title': 'SRT Motor Latency Session 1', 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'SRT Motor Latency Session 2', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'SRT Saccade Latency Session 1', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '0.20', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'SRT Saccade Latency Session 2', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '0.20', 'spread': '0.05', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Days', 'description': '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.', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.'}, {'type': 'PRIMARY', 'title': 'Vestibular Subjective Visual Vertical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Repeatability Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Time of Day Group', 'description': '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.'}, {'id': 'OG002', 'title': 'Learning Affect Group', 'description': '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.'}], 'classes': [{'title': 'Session 1', 'categories': [{'measurements': [{'value': '2.08', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '2.36', 'groupId': 'OG001'}, {'value': '1.21', 'spread': '2.02', 'groupId': 'OG002'}]}]}, {'title': 'Session 2', 'categories': [{'measurements': [{'value': '1.52', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '2.17', 'groupId': 'OG001'}, {'value': '1.64', 'spread': '1.87', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Days', 'description': '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.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.'}, {'type': 'PRIMARY', 'title': 'Vestibular Smooth Pursuit Horizontal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Repeatability Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Time of Day Group', 'description': '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.'}, {'id': 'OG002', 'title': 'Learning Affect Group', 'description': '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.'}], 'classes': [{'title': 'Session 1', 'categories': [{'measurements': [{'value': '10006', 'spread': '815', 'groupId': 'OG000'}, {'value': '10739', 'spread': '849', 'groupId': 'OG001'}, {'value': '10303', 'spread': '905', 'groupId': 'OG002'}]}]}, {'title': 'Session 2', 'categories': [{'measurements': [{'value': '9986', 'spread': '754', 'groupId': 'OG000'}, {'value': '10450', 'spread': '818', 'groupId': 'OG001'}, {'value': '10219', 'spread': '1009', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Days', 'description': '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.', 'unitOfMeasure': 'degree squared per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.'}, {'type': 'PRIMARY', 'title': 'Vestibular Percentage of Saccade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Repeatability Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Time of Day Group', 'description': '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.'}, {'id': 'OG002', 'title': 'Learning Affect Group', 'description': '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.'}], 'classes': [{'title': 'SPH Session 1', 'categories': [{'measurements': [{'value': '12.83', 'spread': '12.14', 'groupId': 'OG000'}, {'value': '16.49', 'spread': '9.80', 'groupId': 'OG001'}, {'value': '21.23', 'spread': '13.70', 'groupId': 'OG002'}]}]}, {'title': 'SPH Session 2', 'categories': [{'measurements': [{'value': '12.72', 'spread': '5.79', 'groupId': 'OG000'}, {'value': '14.38', 'spread': '8.38', 'groupId': 'OG001'}, {'value': '18.23', 'spread': '9.43', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Days', 'description': '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.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.'}, {'type': 'PRIMARY', 'title': 'Vestibular Anti-Saccade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Repeatability Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Time of Day Group', 'description': '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.'}, {'id': 'OG002', 'title': 'Learning Affect Group', 'description': '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.'}], 'classes': [{'title': 'Session 1', 'categories': [{'measurements': [{'value': '39.09', 'spread': '28.74', 'groupId': 'OG000'}, {'value': '23.75', 'spread': '17.16', 'groupId': 'OG001'}, {'value': '34.56', 'spread': '24.42', 'groupId': 'OG002'}]}]}, {'title': 'Session 2', 'categories': [{'measurements': [{'value': '28.17', 'spread': '26.33', 'groupId': 'OG000'}, {'value': '21.88', 'spread': '15.11', 'groupId': 'OG001'}, {'value': '24.26', 'spread': '17.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Days', 'description': '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.', 'unitOfMeasure': 'percentage of error', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.'}, {'type': 'PRIMARY', 'title': 'Vestibular Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Repeatability Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Time of Day Group', 'description': '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.'}, {'id': 'OG002', 'title': 'Learning Affect Group', 'description': '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.'}], 'classes': [{'title': 'OKN Session 1', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '0.79', 'spread': '0.09', 'groupId': 'OG002'}]}]}, {'title': 'OKN Session 2', 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '0.77', 'spread': '0.10', 'groupId': 'OG002'}]}]}, {'title': 'SPH Session 1', 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'SPH Session 2', 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.95', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Days', 'description': '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)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.'}, {'type': 'PRIMARY', 'title': 'Vestibular Saccade Horizontal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Repeatability Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Time of Day Group', 'description': '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.'}, {'id': 'OG002', 'title': 'Learning Affect Group', 'description': '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.'}], 'classes': [{'title': 'Session 1', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.02', 'groupId': 'OG002'}]}]}, {'title': 'Session 2', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.03', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Days', 'description': '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.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.'}, {'type': 'PRIMARY', 'title': 'Vestibular Predictive Saccade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Repeatability Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Time of Day Group', 'description': '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.'}, {'id': 'OG002', 'title': 'Learning Affect Group', 'description': '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.'}], 'classes': [{'title': 'PS Session 1', 'categories': [{'measurements': [{'value': '37.04', 'spread': '18.21', 'groupId': 'OG000'}, {'value': '36.52', 'spread': '21.99', 'groupId': 'OG001'}, {'value': '35.88', 'spread': '18.94', 'groupId': 'OG002'}]}]}, {'title': 'PS Session 2', 'categories': [{'measurements': [{'value': '32.66', 'spread': '21.34', 'groupId': 'OG000'}, {'value': '27.50', 'spread': '20.79', 'groupId': 'OG001'}, {'value': '35.12', 'spread': '24.51', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Days', 'description': '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.', 'unitOfMeasure': 'percentage of prediction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.'}, {'type': 'PRIMARY', 'title': 'Motion Sickness as Measured by the MSAQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MSQ Group', 'description': '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.'}], 'timeFrame': 'Day 1', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the MSQ Groups were the only intended participants to be assessed for this outcome. No participants completed the study for this arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Repeatability Group', 'description': '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.'}, {'id': 'FG001', 'title': 'Time of Day Group', 'description': '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.'}, {'id': 'FG002', 'title': 'Learning Affect Group', 'description': '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.'}, {'id': 'FG003', 'title': 'MSQ Group', 'description': '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.'}, {'id': 'FG004', 'title': 'OKN Only Group', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '78', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Repeatability Group', 'description': '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.'}, {'id': 'BG001', 'title': 'Time of Day Group', 'description': '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.'}, {'id': 'BG002', 'title': 'Learning Affect Group', 'description': '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.'}, {'id': 'BG003', 'title': 'MSQ Group', 'description': '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.'}, {'id': 'BG004', 'title': 'OKN Only Group', 'description': '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.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '78', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2016-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2017-06-07', 'resultsFirstSubmitDate': '2019-10-01', 'studyFirstSubmitQcDate': '2017-06-07', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-03', 'studyFirstPostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vestibular Reaction Times', 'timeFrame': '2 Days', 'description': '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.'}, {'measure': 'Vestibular Subjective Visual Vertical', 'timeFrame': '2 Days', 'description': '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.'}, {'measure': 'Vestibular Smooth Pursuit Horizontal', 'timeFrame': '2 Days', 'description': '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.'}, {'measure': 'Vestibular Percentage of Saccade', 'timeFrame': '2 Days', 'description': '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.'}, {'measure': 'Vestibular Anti-Saccade', 'timeFrame': '2 Days', 'description': '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.'}, {'measure': 'Vestibular Gain', 'timeFrame': '2 Days', 'description': '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)'}, {'measure': 'Vestibular Saccade Horizontal', 'timeFrame': '2 Days', 'description': '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.'}, {'measure': 'Vestibular Predictive Saccade', 'timeFrame': '2 Days', 'description': '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.'}, {'measure': 'Motion Sickness as Measured by the MSAQ', 'timeFrame': 'Day 1', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dizziness']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 65\n* Both Females and males\n* Staff and students at all levels at the University of Miami or first-degree - relatives/significant others of those individuals.\n\nExclusion Criteria:\n\n* History of vestibular disorder/dysfunction\n* Central processing disorder\n* Impaired vision without corrective lenses (max 20/60 uncorrected)\n* Moderate to severe hearing loss \\[\\>55 decibel (dB) Pure Tone Average (PTA), \\<50% word identification\\]'}, 'identificationModule': {'nctId': 'NCT03182868', 'briefTitle': 'Vestibular Testing: Consistency and Effects Over Time', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Vestibular Testing: Consistency and Effects Over Time', 'orgStudyIdInfo': {'id': '20150663'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Repeatability Group', 'description': '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.', 'interventionNames': ['Device: PAS Goggle']}, {'type': 'EXPERIMENTAL', 'label': 'Time of Day Group', 'description': '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.', 'interventionNames': ['Device: PAS Goggle']}, {'type': 'EXPERIMENTAL', 'label': 'Learning Affect Group', 'description': '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.', 'interventionNames': ['Device: PAS Goggle']}, {'type': 'EXPERIMENTAL', 'label': 'MSQ Group', 'description': '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.', 'interventionNames': ['Device: PAS Goggle']}, {'type': 'EXPERIMENTAL', 'label': 'OKN Only Group', 'description': '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.', 'interventionNames': ['Device: PAS Goggle']}], 'interventions': [{'name': 'PAS Goggle', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Learning Affect Group', 'MSQ Group', 'OKN Only Group', 'Repeatability Group', 'Time of Day Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Michael Hoffer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Otolaryngology', 'investigatorFullName': 'Michael E. Hoffer', 'investigatorAffiliation': 'University of Miami'}}}}