Fatigue Countermeasure Program in Operational Flight Controllers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01744678|
Recruitment Status : Completed
First Posted : December 7, 2012
Last Update Posted : January 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Fatigue||Behavioral: blue-wavelength enriched ceiling light Behavioral: mild exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Experimental Trial of Fatigue Countermeasure Program in Operational Flight Controllers|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: Access to experimental break room
Subjects will visit the experimental break room 4 times per Orbit 1 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.
- 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)
- 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)
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744678
|United States, Texas|
|Johnson Space Center|
|Houston, Texas, United States, 77058|
|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|