- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02755493
Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control
July 9, 2018 updated by: Elizabeth B. Klerman, Brigham and Women's Hospital
Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control"
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sleep Deprivation
Sleep deprivation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance metrics on simulated robotic tasks - time
Time Frame: 72 hours
|
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.
|
72 hours
|
|
Performance metrics on simulated robotic tasks - number complete
Time Frame: 72 hours
|
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.
|
72 hours
|
|
Performance metrics on simulated robotic tasks - resources uses
Time Frame: 72 hours
|
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.
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
May 31, 2017
Study Completion (Actual)
May 31, 2018
Study Registration Dates
First Submitted
April 18, 2016
First Submitted That Met QC Criteria
April 26, 2016
First Posted (Estimate)
April 29, 2016
Study Record Updates
Last Update Posted (Actual)
July 11, 2018
Last Update Submitted That Met QC Criteria
July 9, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HFP04201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Christian BaumannCompletedAcute and Partial Sleep DeprivationSwitzerland
-
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Dr. Osman HospitalCairo UniversityUnknownEffect of Insomnia and Sleep Deprivation in 3rdtrimesterEgypt
-
Hallym University Medical CenterCompletedWe Investigated the Effect of Sleep Deprivation on the Tear Film and Ocular Surface.Korea, Republic of
-
Emily GusemanCompleted
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-
University of UtahEpitel, Inc.TerminatedSleep | Sleep DeprivationUnited States
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Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloUnknownSleep | Sleep DeprivationBrazil
Clinical Trials on Sleep deprivation
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Federal University of São PauloCompleted
-
Centre Hospitalier Universitaire de Saint EtienneJean Monnet UniversityRecruiting
-
Esther WerthCompletedIdiopathic Hypersomnia | Narcolepsy 1Switzerland
-
University of OttawaCompletedSleep Disturbance | Exercise | Aging | Thermoregulation | Heat ExchangeCanada
-
University of ZurichFonds für Verkehrssicherheit FVSCompletedSleep Deprivation | Sleepiness | Insufficient Sleep SyndromeSwitzerland
-
Boston University Charles River CampusBrain & Behavior Research Foundation; One Mind; 1907 FoundationRecruiting
-
Yoav GimonCompleted
-
Charite University, Berlin, GermanyCompleted