Fatigue Countermeasure Program in Operational Flight Controllers

January 16, 2019 updated by: Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital

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:

  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 Overview

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77058
        • Johnson Space Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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.

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
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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

October 11, 2012

First Submitted That Met QC Criteria

December 5, 2012

First Posted (Estimate)

December 7, 2012

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 16, 2019

Last Verified

January 1, 2019

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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