Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-27 @ 3:24 AM
Study NCT ID:
NCT02755493
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2016-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}], 'ancestors': [{'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-09', 'studyFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance metrics on simulated robotic tasks - time', 'timeFrame': '72 hours', 'description': 'Over this 72 hour time frame there will be six assessments. Once on Day1, 4 times during the sleep deprivation on Days 2-3, and once on Day 4, the participant will perform computer simulations of "missions" with tasks. The time to complete tasks will be one of the metrics. The change in metrics related to length of time of awake will be assessed using longitudinal analysis methods.'}, {'measure': 'Performance metrics on simulated robotic tasks - number complete', 'timeFrame': '72 hours', 'description': 'Over this 72 hour time frame there will be six assessments Once on Day1, 4 times during the sleep deprivation on Days 2-3, and once on Day 4, the participant will perform computer simulations of "missions" with tasks. The number of completed tasks will be one of the metrics.The change in metrics related to length of time of awake will be assessed using longitudinal analysis methods.'}, {'measure': 'Performance metrics on simulated robotic tasks - resources uses', 'timeFrame': '72 hours', 'description': 'Over this 72 hour time frame there will be six assessments Once on Day1, 4 times during the sleep deprivation on Days 2-3, and once on Day 4, the participant will perform computer simulations of "missions" with tasks. The resources used will be one of the metrics.The change in metrics related to length of time of awake will be assessed using longitudinal analysis methods.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sleep Deprivation']}, 'descriptionModule': {'briefSummary': 'This project proposes to both develop and test adaptive automation countermeasures for the effects of stressors such as sleep deprivation (SD) on human performance related to robotic tasks, and investigate the relationship between human trust and appropriate use of these countermeasures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy by history, physical exam, laboratory evaluations of urine and blood, electrocardiogram (ECG), psychological screening, and self-reported sleep quality.\n* engineering or computer programming experience\n\nExclusion Criteria:\n\n* color blind\n* pregnant or nursing\n* using any prescription or non-prescription medications, caffeine, alcohol or tobacco for the three weeks prior to beginning the inpatient experiments'}, 'identificationModule': {'nctId': 'NCT02755493', 'briefTitle': 'Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control"', 'orgStudyIdInfo': {'id': 'HFP04201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep Deprivation', 'description': 'Sleep deprivation', 'interventionNames': ['Behavioral: Sleep deprivation']}], 'interventions': [{'name': 'Sleep deprivation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Sleep Deprivation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Elizabeth B Klerman, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Space Biomedical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Elizabeth B. Klerman', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}