Houston, Texas 77058

  • Fatigue

Purpose:

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: 1. 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. 2. 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. 3. 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. 4. 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. 5. 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 summary:

Each participant will have three data collection periods. Each data collection period will last one shift rotation (5 -7 days): One 5-shift or 7-shift block of Orbit 1 night shifts on console with access to photic and exercise countermeasures, a second 5-shift or 7-shift block of Orbit 1 night shifts on console with no access to countermeasures, and a third 5-shift block of daytime office work off console. We will be measuring sleep via a wrist worn activity measuring device and compliance of exercise intervention via a small, commercially available heart monitor worn around the chest underneath clothing. The activity device will be worn continuously and the heart monitor will be worn on shift. These devices will be downloaded at the end of each block of shifts. Subjects will complete a short baseline questionnaire once at the beginning of the study. Subjective alertness will be assessed with the Karolinska Sleepiness Scale (KSS), performance testing will occur regularly and 'end of shift' questionnaires will be completed at the end of each shift. Drowsiness will be measured on the commute to and from work with the Optalert.


Criteria:

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:


Study is Available At:


Original ID:

NNX10AF47G


NCT ID:

NCT01744678


Secondary ID:


Study Acronym:


Brief Title:

Fatigue Countermeasure Program in Operational Flight Controllers


Official Title:

Experimental Trial of Fatigue Countermeasure Program in Operational Flight Controllers


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Brigham and Women's Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Charles A Czeisler, PhD, MD
Principal Investigator
Brigham and Women's Hospital / Harvard Medical School

Study Dates

Start Date:September 2012
Completion Date:November 2012
Completion Type:Actual
Primary Completion Date:November 2012
Primary Completion Type:Actual
Verification Date:January 2019
Last Changed Date:January 16, 2019
First Received Date:October 11, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Sleep duration as captured in sleep/work logs
Time Frame:Three weeks.
Safety Issues:False
Description:Average hours of sleep per 24hr day by condition (day shift, overnight control, overnight intervention)
Outcome Type:Secondary Outcome
Measure:Sleep duration as measured by wrist actigraphy
Time Frame:Three weeks.
Safety Issues:False
Description:Average hours of sleep per 24hr day by condition (day shift, overnight control, overnight intervention)
Outcome Type:Primary Outcome
Measure:Alertness/Fatigue as measured by Psychomotor Vigilance Task and Visual Analog Scales
Time Frame:Three weeks.
Safety Issues:False
Description: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)

Study Interventions

Intervention Type:Behavioral
Name:mild exercise
Description: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.
Arm Name:Access to experimental break room
Other Name:ICON Health and Fitness Pro2000 Treadmill PFTL1301
Intervention Type:Behavioral
Name:blue-wavelength enriched ceiling light
Description:Subjects will be in the experimental break room for four 20-minute periods for each Orbit 1 work shift.
Arm Name:Access to experimental break room
Other Name:Sylvania Fluorescent Octron FO32/SKYWHITE/XP/ECO 8

Study Arms

Study Arm Type:Experimental
Arm Name:Access to experimental break room
Description:Subjects will visit the experimental break room 4 times per Orbit 1 shift: first, prior to the beginning of the work shift second, during an operationally feasible 20-min break during the 1st half of the work shift third, once during an operationally feasible 20-min break during the 2nd half of the work shift fourth, immediately after the end of the work shift In the break room, subjects will be passively exposed to blue-wavelength enriched ceiling lights during all four visits for each wor

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Brigham and Women's Hospital
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:National Aeronautics and Space Administration (NASA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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