NCT02755493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

April 18, 2016

Last Update Submit

July 9, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    72 hours

Study Arms (1)

Sleep Deprivation

EXPERIMENTAL

Sleep deprivation

Behavioral: Sleep deprivation

Interventions

Sleep Deprivation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Elizabeth B Klerman, MD PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 29, 2016

Study Start

April 1, 2016

Primary Completion

May 31, 2017

Study Completion

May 31, 2018

Last Updated

July 11, 2018

Record last verified: 2018-07

Locations