Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-29 @ 2:27 PM
Study NCT ID:
NCT02136420
Status:
COMPLETED
Last Update Posted:
2018-01-08
First Post:
2014-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011398', 'term': 'Promethazine'}, {'id': 'D013213', 'term': 'Starch'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'faisal_karmali@meei.harvard.edu', 'phone': '617-573-5593', 'title': 'Faisal Karmali', 'organization': 'Massachusetts Eye and Ear Infirmary'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 week', 'eventGroups': [{'id': 'EG000', 'title': 'Tilt Perception, Training, Placebo', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tilt Perception, No Training, Placebo', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Tilt Perception, Training, Promethazine', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Tilt Perception, No Training, Promethazine', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Perceptual Threshold Testing: Promethazine', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Perceptual Motion Threshold Testing: Placebo', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Manual Control, Training, Placebo', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Manual Control, No Training, Placebo', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Manual Control, Training, Promethazine', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Manual Control, No Training, Promethazine', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Roll Tilt Perception After Exposure to Hypogravity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Training, Placebo', 'description': 'placebo\n\nHyper gravity training: Subject receives hypergravity training before testing\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '57.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 session', 'description': 'Note that this applies to arms 1-4 only.\n\nSubjects sat on a chair on a moving platform on top of a centrifuge that created an artificial gravity environment. Subjects were repeatedly roll tilted to angles between 11 and 19 degrees, and then reported their perceived tilt angle using a subjective visual vertical task. They did this while experiencing centripetal acceleration equivalent to Earth gravity (1 Gz), and then hypogravity (0.5 Gz). We hypothesized that, after entering hypogravity, subjects would tend to underestimate their tilt angle. We calculated the percent change in their perception of tilt between 1 Gz and 0.5 Gz.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Yaw Perceptual Motion Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Perceptual Thresholds,Drug Then Placebo', 'description': 'Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by \\>4 days.\n\nPromethazine: Subject receives promethazine\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': 'Perceptual Thresholds,Placebo Then Drug', 'description': 'Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by \\>4 days.'}], 'classes': [{'title': 'Placebo', 'categories': [{'measurements': [{'value': '.83', 'spread': '.25', 'groupId': 'OG000'}, {'value': '.92', 'spread': '.29', 'groupId': 'OG001'}]}]}, {'title': 'Promethazine', 'categories': [{'measurements': [{'value': '.86', 'spread': '.19', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '.26', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication', 'description': 'This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Yaw rotation means rotations about an axis that is perpendicular to gravity.\n\nThis outcome measure applies only to arm 5 subjects.', 'unitOfMeasure': 'deg per sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Roll Perceptual Motion Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Perceptual Thresholds,Drug Then Placebo', 'description': 'Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by \\>4 days.\n\nPromethazine: Subject receives promethazine\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': 'Perceptual Thresholds,Placebo Then Drug', 'description': 'Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by \\>4 days.'}], 'classes': [{'title': 'Placebo', 'categories': [{'measurements': [{'value': '.27', 'spread': '.15', 'groupId': 'OG000'}, {'value': '.32', 'spread': '.12', 'groupId': 'OG001'}]}]}, {'title': 'Promethazine', 'categories': [{'measurements': [{'value': '.39', 'spread': '.20', 'groupId': 'OG000'}, {'value': '.39', 'spread': '.13', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication', 'description': 'This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Roll tilt means rotations about an axis that is Earth-horizontal.\n\nThis outcome measure applies only to arm 5 subjects.', 'unitOfMeasure': 'deg per sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Interaural Perceptual Motion Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Perceptual Thresholds,Drug Then Placebo', 'description': 'Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by \\>4 days.\n\nPromethazine: Subject receives promethazine\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': 'Perceptual Thresholds,Placebo Then Drug', 'description': 'Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by \\>4 days.'}], 'classes': [{'title': 'Placebo', 'categories': [{'measurements': [{'value': '.57', 'spread': '.17', 'groupId': 'OG000'}, {'value': '.78', 'spread': '.23', 'groupId': 'OG001'}]}]}, {'title': 'Promethazine', 'categories': [{'measurements': [{'value': '.77', 'spread': '.39', 'groupId': 'OG000'}, {'value': '.80', 'spread': '.16', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication', 'description': "This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Interaural translation refers to translations in the horizontal plane to the subject's left or right.\n\nThis outcome measure applies only to arm 5 subjects.", 'unitOfMeasure': 'cm per sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change in Manual Control Performance After Exposure to Hypogravity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Training, Placebo', 'description': 'placebo\n\nHyper gravity training: Subject receives hypergravity training before testing\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '75.4', 'spread': '48.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 session', 'description': 'Note that this applies to arms 6-9 only.\n\nSubjects sat on a chair on a moving platform on top of a centrifuge that created an artificial gravity environment. Subjects completed a manual control task in which their charge was randomly perturbed in roll tilt, and they used a joystick to attempt to keep themselves aligned with upright, while in the dark. They did this while experiencing centripetal acceleration equivalent to Earth gravity (1 Gz), and then hypogravity (0.5 Gz). We calculated their performance by calculating the standard deviation of chair position across time, with a smaller number indicating better performance. Then we calculated the percent change in their performance between 1 Gz and 0.5 Gz.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tilt Perception, Training, Placebo', 'description': 'placebo'}, {'id': 'FG001', 'title': 'Tilt Perception, No Training, Placebo', 'description': 'subject does test with no hypergravity training and placebo drug only'}, {'id': 'FG002', 'title': 'Tilt Perception, Training, Promethazine', 'description': 'promethazine 25 mg, one time 120 minutes prior to experiment'}, {'id': 'FG003', 'title': 'Tilt Perception,No Training,Promethazine', 'description': 'promethazine 25 mg, one time 120 minutes prior to experiment. No hypergravity training'}, {'id': 'FG004', 'title': 'Manual Control, Training, Placebo', 'description': 'placebo'}, {'id': 'FG005', 'title': 'Manual Control, No Training, Placebo', 'description': 'subject does test with no hyper gravity training and placebo drug only'}, {'id': 'FG006', 'title': 'Manual Control, Training, Promethazine', 'description': 'promethazine 25 mg, one time 120 minutes prior to experiment'}, {'id': 'FG007', 'title': 'Manual Control,No Training,Promethazine', 'description': 'promethazine 25 mg, one time 120 minutes prior to experiment'}, {'id': 'FG008', 'title': 'Perceptual Thresholds,Drug Then Placebo', 'description': 'Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by \\>4 days.\n\nThis arm corresponds to results published in Diaz-Artiles et al 2017.'}, {'id': 'FG009', 'title': 'Perceptual Thresholds,Placebo Then Drug', 'description': 'Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by \\>4 days.\n\nThis arm corresponds to results published in Diaz-Artiles et al 2017.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Tilt Perception, Training, Placebo', 'description': 'placebo\n\nHyper gravity training: Subject receives hypergravity training before testing\n\nPlacebo: Placebo'}, {'id': 'BG001', 'title': 'Manual Control, Training, Placebo', 'description': 'placebo\n\nHyper gravity training: Subject receives hypergravity training before testing\n\nPlacebo: Placebo'}, {'id': 'BG002', 'title': 'Perceptual Thresholds,Drug Then Placebo', 'description': 'Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by \\>4 days.\n\nPromethazine: Subject receives promethazine\n\nPlacebo: Placebo'}, {'id': 'BG003', 'title': 'Perceptual Thresholds,Placebo Then Drug', 'description': 'Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by \\>4 days.\n\nPromethazine: Subject receives promethazine\n\nPlacebo: Placebo'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '28.0', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '27.4', 'spread': '4.2', 'groupId': 'BG002'}, {'value': '24.8', 'spread': '2.9', 'groupId': 'BG003'}, {'value': '27.6', 'spread': '4.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double masking applies to arms 9\\&10. Other arms use participant masking only.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The design includes three separate studies:\n\n1. Arm 9\\&10 follows a crossover design. These results were reported in Diaz-Artiles et al 2017.\n2. Arms 1-4 are a separate study which follow a factorial design, with arm 2 serving as the placebo, arms 1 and 3 assessing the effects of two separate interventions and arm 4 assessing the effect of two combined interventions.\n3. Arms 5-8 are a separate study which follow a factorial design, with arm 6 serving as the placebo, arms 5 and 7 assessing the effects of two separate interventions and arm 8 assessing the effect of two combined interventions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-07', 'studyFirstSubmitDate': '2014-04-30', 'resultsFirstSubmitDate': '2017-08-16', 'studyFirstSubmitQcDate': '2014-05-08', 'lastUpdatePostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-07', 'studyFirstPostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Roll Tilt Perception After Exposure to Hypogravity', 'timeFrame': '1 session', 'description': 'Note that this applies to arms 1-4 only.\n\nSubjects sat on a chair on a moving platform on top of a centrifuge that created an artificial gravity environment. Subjects were repeatedly roll tilted to angles between 11 and 19 degrees, and then reported their perceived tilt angle using a subjective visual vertical task. They did this while experiencing centripetal acceleration equivalent to Earth gravity (1 Gz), and then hypogravity (0.5 Gz). We hypothesized that, after entering hypogravity, subjects would tend to underestimate their tilt angle. We calculated the percent change in their perception of tilt between 1 Gz and 0.5 Gz.'}, {'measure': 'Yaw Perceptual Motion Threshold', 'timeFrame': '2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication', 'description': 'This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Yaw rotation means rotations about an axis that is perpendicular to gravity.\n\nThis outcome measure applies only to arm 5 subjects.'}, {'measure': 'Roll Perceptual Motion Threshold', 'timeFrame': '2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication', 'description': 'This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Roll tilt means rotations about an axis that is Earth-horizontal.\n\nThis outcome measure applies only to arm 5 subjects.'}, {'measure': 'Interaural Perceptual Motion Threshold', 'timeFrame': '2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication', 'description': "This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Interaural translation refers to translations in the horizontal plane to the subject's left or right.\n\nThis outcome measure applies only to arm 5 subjects."}, {'measure': 'Percent Change in Manual Control Performance After Exposure to Hypogravity', 'timeFrame': '1 session', 'description': 'Note that this applies to arms 6-9 only.\n\nSubjects sat on a chair on a moving platform on top of a centrifuge that created an artificial gravity environment. Subjects completed a manual control task in which their charge was randomly perturbed in roll tilt, and they used a joystick to attempt to keep themselves aligned with upright, while in the dark. They did this while experiencing centripetal acceleration equivalent to Earth gravity (1 Gz), and then hypogravity (0.5 Gz). We calculated their performance by calculating the standard deviation of chair position across time, with a smaller number indicating better performance. Then we calculated the percent change in their performance between 1 Gz and 0.5 Gz.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vestibular']}, 'referencesModule': {'references': [{'pmid': '28439720', 'type': 'RESULT', 'citation': 'Diaz-Artiles A, Priesol AJ, Clark TK, Sherwood DP, Oman CM, Young LR, Karmali F. The Impact of Oral Promethazine on Human Whole-Body Motion Perceptual Thresholds. J Assoc Res Otolaryngol. 2017 Aug;18(4):581-590. doi: 10.1007/s10162-017-0622-z. Epub 2017 Apr 24.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will study adaptation of motion perception and manual control in altered gravity, including the effects of a drug (promethazine). The investigators will also study whether promethazine affects motion perceptual thresholds.', 'detailedDescription': "Adaptation to altered gravity has been of concern from the earliest reports of space motion sickness, through the Apollo exploration era, and into current planning of exploration missions. The proposed research program takes a new approach which could lead to an effective, practical and acceptable protocol for preadapting astronauts to space flight. By using the gravito-inertial alterations possible with centrifugation in different body orientations the investigators will quantify an individual's sensory adaptation capability and use it to predict and to minimize the consequences of movement in any other gravity environment - eventually including weightlessness. The investigators will also study whether a drug (promethazine) affects motion perception and motion sickness."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be in general good health\n\nExclusion Criteria:\n\n* Anyone who is not generally in good general health does not qualify\n* Cardiovascular disease\n* Severe diabetes\n* Respiratory condition (e.g. asthma or emphysema)\n* Narrow angle glaucoma\n* Prostatic hypertrophy\n* Gastrointestinal disorders'}, 'identificationModule': {'nctId': 'NCT02136420', 'briefTitle': 'Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts Eye and Ear Infirmary'}, 'officialTitle': 'Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels', 'orgStudyIdInfo': {'id': '497997'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tilt perception, Training, placebo', 'description': 'placebo', 'interventionNames': ['Behavioral: Hyper gravity training', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Tilt perception, No training, placebo', 'description': 'subject does test with no hypergravity training and placebo drug only', 'interventionNames': ['Drug: Placebo', 'Behavioral: No hypergravity training']}, {'type': 'EXPERIMENTAL', 'label': 'Tilt perception, Training, promethazine', 'description': 'promethazine 25 mg, one time 120 minutes prior to experiment', 'interventionNames': ['Drug: Promethazine', 'Behavioral: Hyper gravity training']}, {'type': 'EXPERIMENTAL', 'label': 'Tilt perception,No training,promethazine', 'description': 'promethazine 25 mg, one time 120 minutes prior to experiment. No hypergravity training', 'interventionNames': ['Drug: Promethazine', 'Behavioral: No hypergravity training']}, {'type': 'EXPERIMENTAL', 'label': 'Manual Control, Training, placebo', 'description': 'placebo', 'interventionNames': ['Behavioral: Hyper gravity training', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Manual Control, No training, placebo', 'description': 'subject does test with no hyper gravity training and placebo drug only', 'interventionNames': ['Drug: Placebo', 'Behavioral: No hypergravity training']}, {'type': 'EXPERIMENTAL', 'label': 'Manual Control, Training, promethazine', 'description': 'promethazine 25 mg, one time 120 minutes prior to experiment', 'interventionNames': ['Drug: Promethazine', 'Behavioral: Hyper gravity training']}, {'type': 'EXPERIMENTAL', 'label': 'Manual Control,No training,promethazine', 'description': 'promethazine 25 mg, one time 120 minutes prior to experiment', 'interventionNames': ['Drug: Promethazine', 'Behavioral: No hypergravity training']}, {'type': 'EXPERIMENTAL', 'label': 'Perceptual thresholds,drug then placebo', 'description': 'Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by \\>4 days.\n\nThis arm corresponds to results published in Diaz-Artiles et al 2017.', 'interventionNames': ['Drug: Promethazine', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Perceptual thresholds,placebo then drug', 'description': 'Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by \\>4 days.\n\nThis arm corresponds to results published in Diaz-Artiles et al 2017.', 'interventionNames': ['Drug: Promethazine', 'Drug: Placebo']}], 'interventions': [{'name': 'Promethazine', 'type': 'DRUG', 'otherNames': ['Phenergan'], 'description': 'Subject receives promethazine', 'armGroupLabels': ['Manual Control, Training, promethazine', 'Manual Control,No training,promethazine', 'Perceptual thresholds,drug then placebo', 'Perceptual thresholds,placebo then drug', 'Tilt perception, Training, promethazine', 'Tilt perception,No training,promethazine']}, {'name': 'Hyper gravity training', 'type': 'BEHAVIORAL', 'description': 'Subject receives hypergravity training before testing', 'armGroupLabels': ['Manual Control, Training, placebo', 'Manual Control, Training, promethazine', 'Tilt perception, Training, placebo', 'Tilt perception, Training, promethazine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['corn starch'], 'description': 'Placebo', 'armGroupLabels': ['Manual Control, No training, placebo', 'Manual Control, Training, placebo', 'Perceptual thresholds,drug then placebo', 'Perceptual thresholds,placebo then drug', 'Tilt perception, No training, placebo', 'Tilt perception, Training, placebo']}, {'name': 'No hypergravity training', 'type': 'BEHAVIORAL', 'description': 'Subjects do not receive normal Earth gravity', 'armGroupLabels': ['Manual Control, No training, placebo', 'Manual Control,No training,promethazine', 'Tilt perception, No training, placebo', 'Tilt perception,No training,promethazine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Eye and Ear Infirmary', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Faisal Karmali, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts Eye and Ear Infirmary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faisal_Karmali@MEEI.HARVARD.EDU', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Space Biomedical Research Institute', 'class': 'OTHER'}, {'name': 'Massachusetts Institute of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Faisal_Karmali@MEEI.HARVARD.EDU', 'investigatorAffiliation': 'Massachusetts Eye and Ear Infirmary'}}}}