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Completed

NCT Number: NCT01744678

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johnson Space Center

Houston, Texas, 77058, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blue-wavelength enriched ceiling light

Behavioral

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

mild exercise

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Aeronautics and Space Administration (NASA)

Registry information

Official study title

Experimental Trial of Fatigue Countermeasure Program in Operational Flight Controllers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 7, 2012
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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