Fatigue Countermeasure Program in Operational Flight Controllers

This study has been completed.
Sponsor:
Collaborator:
National Aeronautics and Space Administration (NASA)
Information provided by (Responsible Party):
Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01744678
First received: October 11, 2012
Last updated: December 5, 2012
Last verified: December 2012
  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 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 Intervention
Fatigue
Behavioral: blue-wavelength enriched ceiling light
Behavioral: mild exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Experimental Trial of Fatigue Countermeasure Program in Operational Flight Controllers

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Alertness/Fatigue as measured by Psychomotor Vigilance Task and Visual Analog Scales [ Time Frame: Three weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep duration as measured by wrist actigraphy [ Time Frame: Three weeks. ] [ Designated as safety issue: No ]
  • Sleep duration as captured in sleep/work logs [ Time Frame: Three weeks. ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 NASA scheduling operational constraints

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744678

Locations
United States, Texas
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
  More Information

No publications provided

Responsible Party: Charles Andrew Czeisler, MD, PhD, Chief, Division of Sleep Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01744678     History of Changes
Other Study ID Numbers: NNX10AF47G
Study First Received: October 11, 2012
Last Updated: December 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014