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Fatigue Countermeasure Program in Operational Flight Controllers

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
blue-wavelength enriched ceiling light
mild exercise
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johnson Space Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Access to experimental break room

Arm 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 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.

Outcomes

Primary Outcome Measures

Alertness/Fatigue as measured by Psychomotor Vigilance Task and Visual Analog Scales
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

Sleep duration as measured by wrist actigraphy
Average hours of sleep per 24hr day by condition (day shift, overnight control, overnight intervention)
Sleep duration as captured in sleep/work logs
Average hours of sleep per 24hr day by condition (day shift, overnight control, overnight intervention)

Full Information

First Posted
October 11, 2012
Last Updated
January 16, 2019
Sponsor
Brigham and Women's Hospital
Collaborators
National Aeronautics and Space Administration (NASA)
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1. Study Identification

Unique Protocol Identification Number
NCT01744678
Brief Title
Fatigue Countermeasure Program in Operational Flight Controllers
Official Title
Experimental Trial of Fatigue Countermeasure Program in Operational Flight Controllers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Aeronautics and Space Administration (NASA)

4. Oversight

Data Monitoring Committee
No

5. 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: 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Access to experimental break room
Arm Type
Experimental
Arm 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 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.
Intervention Type
Behavioral
Intervention Name(s)
blue-wavelength enriched ceiling light
Other Intervention Name(s)
Sylvania Fluorescent Octron FO32/SKYWHITE/XP/ECO 8000K
Intervention Description
Subjects will be in the experimental break room for four 20-minute periods for each Orbit 1 work shift.
Intervention Type
Behavioral
Intervention Name(s)
mild exercise
Other Intervention Name(s)
ICON Health and Fitness Pro2000 Treadmill PFTL13011, ICON Health and Fitness 290SPX Bike PFEX02909
Intervention 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.
Primary Outcome Measure Information:
Title
Alertness/Fatigue as measured by Psychomotor Vigilance Task and Visual Analog Scales
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)
Time Frame
Three weeks.
Secondary Outcome Measure Information:
Title
Sleep duration as measured by wrist actigraphy
Description
Average hours of sleep per 24hr day by condition (day shift, overnight control, overnight intervention)
Time Frame
Three weeks.
Title
Sleep duration as captured in sleep/work logs
Description
Average hours of sleep per 24hr day by condition (day shift, overnight control, overnight intervention)
Time Frame
Three weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles A Czeisler, PhD, MD
Organizational Affiliation
Brigham and Women's Hospital / Harvard Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura K Barger, PhD
Organizational Affiliation
Brigham and Women's Hospital / Harvard Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Johnson Space Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States

12. IPD Sharing Statement

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Fatigue Countermeasure Program in Operational Flight Controllers

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