Sleep DeprivationNCT02755493
Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control
A study testing Sleep deprivation in people with Sleep Deprivation, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Sleep deprivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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.
- Conditions
- Sleep Deprivation
- Being tested
- Sleep deprivation
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep deprivationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Sleep Deprivation | Experimental | Sleep deprivation Receives: Behavioral: Sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
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.
Measured: 72 hours
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion31 May 2017
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Space Biomedical Research Institute
- Responsible party
- Principal investigator, Elizabeth B. Klerman, Brigham and Women's Hospital
- Investigators
- Elizabeth B Klerman, MD PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755493
- Sponsor's protocol ID
- HFP04201
- Status last verified
- Jul 2018
- First submitted
- 18 Apr 2016
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control"
- ClinicalTrials.gov ID
- NCT02755493
- Acronym / sponsor ID
- HFP04201
- Conditions
- Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Space Biomedical Research Institute
- Study start
- Apr 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Deprivation | Experimental | Behavioral: Sleep deprivationSleep deprivation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep deprivation | Behavioural | Sleep Deprivation |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
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Sleep and Circadian Rhythm Intervention in ICU
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth B Klerman, MD PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep deprivation in people with Sleep Deprivation, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance metrics on simulated robotic tasks - time (time frame: 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.