- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01744678
Fatigue Countermeasure Program in Operational Flight Controllers
Experimental Trial of Fatigue Countermeasure Program in Operational Flight Controllers
The purpose of this study is to validate the acceptability, operational feasibility and efficacy of a combined fatigue countermeasure comprised of shorter-wavelength light and exercise during operational Orbit 1 night shifts to improve alertness and performance of flight mission controllers.
Specifically, the investigators will:
- Feasibility. Test the feasibility of developing a break room containing fatigue countermeasures (shorter-wavelength light and exercise equipment) to be used by flight mission controllers during Orbit 1 night shifts, and the feasibility to schedule regular breaks during the Orbit 1 shift so that flight mission controllers have the opportunity to use the fatigue countermeasures break room.
- Acceptability. Test the acceptability of the use of the fatigue countermeasures break room evaluating when and how the room is used by flight mission controllers, as measured on End-of-Shift Productivity Questionnaire.
- Test the hypothesis that alertness and performance will be impaired in flight mission controllers during Orbit 1 operational night shifts as compared to flight mission controllers working a non-console day shift.
- Test the hypothesis that alertness and performance of flight mission controllers who exercise and are exposed to shorter wavelength light during the Orbit 1 night shift will be significantly more alert and have better mood, performance (e.g., less Psychomotor Vigilance Task (PVT) lapses, increased productivity) than those same mission controllers working Orbit 1 night shifts without exposure to the shorter wavelength light and exercise.
- Test the acceptability, operational feasibility and efficacy of implementing an anonymous sleep disorders screening for flight controllers, evaluated by number of visitors to the screening web site and the number of completed assessments.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77058
- Johnson Space Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must be current Johnson Space Center International Space Station Flight Controller or Flight Director cleared to sit console for Orbit 1 work shift
- Work schedule must meet both study needs and National Aeronautics and Space Administration (NASA) scheduling operational constraints
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Access to experimental break room
Subjects will visit the experimental break room 4 times per Orbit 1 shift:
In the break room, subjects will be passively exposed to blue-wavelength enriched ceiling lights during all four visits for each work shift. Also in the break room, subjects will perform 10-minutes of mild exercise during the first three visits to the break room during each work shift. |
Subjects will be in the experimental break room for four 20-minute periods for each Orbit 1 work shift.
Other Names:
Subjects will be asked to achieve 65% of maximum heart rate on either a treadmill or exercise cycle for 10-minutes, three times during each Orbit 1 work shift.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alertness/Fatigue as measured by Psychomotor Vigilance Task and Visual Analog Scales
Time Frame: Three weeks.
|
Average slowest 10% reaction times by condition (day shift, overnight control, overnight intervention), across time within shifts (pre-shift, first half, second half, post-shift), and across consecutive shifts (shifts 1, 2, 3, 4, 5)
|
Three weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep duration as measured by wrist actigraphy
Time Frame: Three weeks.
|
Average hours of sleep per 24hr day by condition (day shift, overnight control, overnight intervention)
|
Three weeks.
|
Sleep duration as captured in sleep/work logs
Time Frame: Three weeks.
|
Average hours of sleep per 24hr day by condition (day shift, overnight control, overnight intervention)
|
Three weeks.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Charles A Czeisler, PhD, MD, Brigham and Women's Hospital / Harvard Medical School
- Study Director: Laura K Barger, PhD, Brigham and Women's Hospital / Harvard Medical School
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NNX10AF47G
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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