Back to resultsQuantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep deprivation
Sponsored by
About this trial
This is an interventional basic science trial for Sleep Deprivation
Eligibility Criteria
Inclusion Criteria:
- healthy by history, physical exam, laboratory evaluations of urine and blood, electrocardiogram (ECG), psychological screening, and self-reported sleep quality.
- engineering or computer programming experience
Exclusion Criteria:
- color blind
- pregnant or nursing
- using any prescription or non-prescription medications, caffeine, alcohol or tobacco for the three weeks prior to beginning the inpatient experiments
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sleep Deprivation
Arm Description
Sleep deprivation
Outcomes
Primary Outcome Measures
Performance metrics on simulated robotic tasks - time
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.
Performance metrics on simulated robotic tasks - number complete
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.
Performance metrics on simulated robotic tasks - resources uses
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02755493
First Posted
April 18, 2016
Last Updated
July 9, 2018
Sponsor
Brigham and Women's Hospital
Collaborators
National Space Biomedical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02755493
Brief Title
Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control
Official Title
Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control"
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Space Biomedical Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep Deprivation
Arm Type
Experimental
Arm Description
Sleep deprivation
Intervention Type
Behavioral
Intervention Name(s)
Sleep deprivation
Primary Outcome Measure Information:
Title
Performance metrics on simulated robotic tasks - time
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.
Time Frame
72 hours
Title
Performance metrics on simulated robotic tasks - number complete
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.
Time Frame
72 hours
Title
Performance metrics on simulated robotic tasks - resources uses
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.
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy by history, physical exam, laboratory evaluations of urine and blood, electrocardiogram (ECG), psychological screening, and self-reported sleep quality.
engineering or computer programming experience
Exclusion Criteria:
color blind
pregnant or nursing
using any prescription or non-prescription medications, caffeine, alcohol or tobacco for the three weeks prior to beginning the inpatient experiments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth B Klerman, MD PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control
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