Fatigue Countermeasure Program in Operational Flight Controllers

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01744678
Collaborator
National Aeronautics and Space Administration (NASA) (U.S. Fed)
20
1
1
2
10

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: blue-wavelength enriched ceiling light
  • Behavioral: mild exercise
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Experimental Trial of Fatigue Countermeasure Program in Operational Flight Controllers
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Nov 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Access to experimental break room

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 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.

Behavioral: blue-wavelength enriched ceiling light
Subjects will be in the experimental break room for four 20-minute periods for each Orbit 1 work shift.
Other Names:
  • Sylvania Fluorescent Octron FO32/SKYWHITE/XP/ECO 8000K
  • Behavioral: mild exercise
    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:
  • ICON Health and Fitness Pro2000 Treadmill PFTL13011
  • ICON Health and Fitness 290SPX Bike PFEX02909
  • Outcome Measures

    Primary Outcome Measures

    1. Alertness/Fatigue as measured by Psychomotor Vigilance Task and Visual Analog Scales [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)

    Secondary Outcome Measures

    1. Sleep duration as measured by wrist actigraphy [Three weeks.]

      Average hours of sleep per 24hr day by condition (day shift, overnight control, overnight intervention)

    2. Sleep duration as captured in sleep/work logs [Three weeks.]

      Average hours of sleep per 24hr day by condition (day shift, overnight control, overnight intervention)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johnson Space Center Houston Texas United States 77058

    Sponsors and Collaborators

    • Brigham and Women's Hospital
    • National Aeronautics and Space Administration (NASA)

    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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Charles Andrew Czeisler, MD, PhD, Chief, Division of Sleep Medicine, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT01744678
    Other Study ID Numbers:
    • NNX10AF47G
    First Posted:
    Dec 7, 2012
    Last Update Posted:
    Jan 18, 2019
    Last Verified:
    Jan 1, 2019
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 18, 2019