NCT01744678

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:

  1. 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. 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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2012

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 7, 2012

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

October 11, 2012

Last Update Submit

January 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    Three weeks.

Secondary Outcomes (2)

  • Sleep duration as measured by wrist actigraphy

    Three weeks.

  • Sleep duration as captured in sleep/work logs

    Three weeks.

Study Arms (1)

Access to experimental break room

EXPERIMENTAL

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 lightBehavioral: mild exercise

Interventions

Subjects will be in the experimental break room for four 20-minute periods for each Orbit 1 work shift.

Also known as: Sylvania Fluorescent Octron FO32/SKYWHITE/XP/ECO 8000K
Access to experimental break room
mild exerciseBEHAVIORAL

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.

Also known as: ICON Health and Fitness Pro2000 Treadmill PFTL13011, ICON Health and Fitness 290SPX Bike PFEX02909
Access to experimental break room

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johnson Space Center

Houston, Texas, 77058, United States

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Charles A Czeisler, PhD, MD

    Brigham and Women's Hospital / Harvard Medical School

    PRINCIPAL INVESTIGATOR
  • Laura K Barger, PhD

    Brigham and Women's Hospital / Harvard Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Sleep Medicine

Study Record Dates

First Submitted

October 11, 2012

First Posted

December 7, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

January 18, 2019

Record last verified: 2019-01

Locations