NCT05524441

Brief Summary

The purpose of the present study is to assess fatigue levels of short-haul pilots during normal operations. The investigators will collect objective and subjective sleep, sleepiness, workload, and performance data from on-duty pilots during short-haul flight operations. Data will be collected during days off prior to the trip start, during flights, and during days off following the flight operations.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

August 31, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

August 18, 2022

Last Update Submit

November 14, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Vigilant Attention

    Measured through the Psychomotor Vigilance Task (PVT) (a simple reaction time task; measures include mean reaction time, response speed (1/RT), and number of lapses (RT \> 500ms))

    up to 26 days

  • Sleep

    Measured through actigraphy which uses accelerometry and a light sensor to determine sleep and wake patterns and may be worn for several weeks at a time

    up to 26 days

  • Fatigue/alertness

    Samn Perelli and Karolinska Sleepiness Scale (KSS): pre- and post-sleep and on-duty fatigue and alertness ratings (as measured by subjective scales) Samn Perelli: 7 point likert scale, 1-7 with higher scores indicating higher levels of fatigue. Karolinska Sleepiness Scale: 9-point likert scale, 1-9 with higher scores indicating higher levels of sleepiness.

    up to 26 days

Study Arms (4)

Airline 1

2 conditions; 18 participants per condition (n = 36)

Other: Circadian Disruption - Quasi-Experimental

Airline 2

2 conditions; 18 participants per condition (n = 36)

Other: Circadian Disruption - Quasi-Experimental

Airline 3

2 conditions; 18 participants per condition (n = 36)

Other: Circadian Disruption - Quasi-Experimental

Airline 4

2 conditions; 18 participants per condition (n = 36)

Other: Circadian Disruption - Quasi-Experimental

Interventions

2 conditions: comparing trips with circadian disruption to trips without circadian disruption

Airline 1Airline 2Airline 3Airline 4

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All subjects will be medically qualified, active-duty flight crewmembers.

You may qualify if:

  • All medically qualified, active-duty pilots currently flying short-haul operations are eligible to be included as participants in the study. Participants must be line pilots that spend at least 50% of their typical monthly schedule flying short-haul operations (defined at flights under 6 hours duration).
  • Participants must be scheduled for and willing to collect data on each of the following:
  • Trip with Circadian Disruption. A trip containing one of the following types of WOCL infringement:
  • Overnight FDPs. An FDP in which the pilot is operating one or more flights through the WOCL (0200-0559h) relative to the pilot's home-base time or clock time.
  • Circadian Switching. At least one FDP that starts between 0000-0659h relative to home-base time, followed by at least one FDP that ends between 0000-0659h, or vice versa, within the same trip (e.g., an FDP that begins at 0500h and the next FDP ends at 0100h or vice versa).
  • AND
  • Trip without Circadian Disruption. This trip must not contain any duties that are scheduled to begin or end between 0000h and 0659h relative to home-base time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NASA Ames Research Center

Mountain View, California, 94043, United States

RECRUITING

Related Publications (13)

  • Bourgeois-Bougrine S, Carbon P, Gounelle C, Mollard R, Coblentz A. Perceived fatigue for short- and long-haul flights: a survey of 739 airline pilots. Aviat Space Environ Med. 2003 Oct;74(10):1072-7.

    PMID: 14556570BACKGROUND
  • Caldwell, J.A., Mallis, M.M., Colletti, L.M., Oyung, R.L., Brandt, S.L., Arsintescu, L., DeRoshia, C.W., Reduta-Rojas, D.D. and Chapman, P.M. (2006). The Effects of Ultra-Long-Range Flights on the Alertness and Performance of Aviators (Report No. TH-066). Ames Research Center. https://ntrs.nasa.gov/citations/20060024526

    BACKGROUND
  • Flight and Duty Limitations and Rest Requirements: Flightcrew Members, 14 C.F.R. § 117 (2012).

    BACKGROUND
  • Flynn-Evans EE, Arsintescu L, Gregory K, Mulligan J, Nowinski J, Feary M. Sleep and neurobehavioral performance vary by work start time during non-traditional day shifts. Sleep Health. 2018 Oct;4(5):476-484. doi: 10.1016/j.sleh.2018.08.002. Epub 2018 Aug 31.

    PMID: 30241664BACKGROUND
  • Gander PH, Gregory KB, Graeber RC, Connell LJ, Miller DL, Rosekind MR. Flight crew fatigue II: short-haul fixed-wing air transport operations. Aviat Space Environ Med. 1998 Sep;69(9 Suppl):B8-15.

    PMID: 9749936BACKGROUND
  • Honn KA, Satterfield BC, McCauley P, Caldwell JL, Van Dongen HP. Fatiguing effect of multiple take-offs and landings in regional airline operations. Accid Anal Prev. 2016 Jan;86:199-208. doi: 10.1016/j.aap.2015.10.005. Epub 2015 Nov 17.

    PMID: 26590506BACKGROUND
  • Mohamed A, Kalavally V, Cain SW, Phillips AJK, McGlashan EM, Tan CP. Wearable light spectral sensor optimized for measuring daily alpha-opic light exposure. Opt Express. 2021 Aug 16;29(17):27612-27627. doi: 10.1364/OE.431373.

    PMID: 34615174BACKGROUND
  • Powell DM, Spencer MB, Holland D, Broadbent E, Petrie KJ. Pilot fatigue in short-haul operations: effects of number of sectors, duty length, and time of day. Aviat Space Environ Med. 2007 Jul;78(7):698-701.

    PMID: 17679568BACKGROUND
  • Roach GD, Sargent C, Darwent D, Dawson D. Duty periods with early start times restrict the amount of sleep obtained by short-haul airline pilots. Accid Anal Prev. 2012 Mar;45 Suppl:22-6. doi: 10.1016/j.aap.2011.09.020. Epub 2011 Oct 10.

    PMID: 22239926BACKGROUND
  • Rosekind MR, Gander PH, Miller DL, Gregory KB, Smith RM, Weldon KJ, Co EL, McNally KL, Lebacqz JV. Fatigue in operational settings: examples from the aviation environment. Hum Factors. 1994 Jun;36(2):327-38. doi: 10.1177/001872089403600212.

    PMID: 8070796BACKGROUND
  • Samel A, Wegmann HM, Vejvoda M. Aircrew fatigue in long-haul operations. Accid Anal Prev. 1997 Jul;29(4):439-52. doi: 10.1016/s0001-4575(97)00023-7.

    PMID: 9248502BACKGROUND
  • Scientific Principles for Fatigue Management. Fatigue Risk Management Systems: Implementation Guide for Operators. Washington, D.C.: International Air Transport Association (IATA), International Federation of Airline Pilots' Associations (IFALPA), and International Civil Aviation Organization (ICAO), 2015.

    BACKGROUND
  • Vejvoda M, Elmenhorst EM, Pennig S, Plath G, Maass H, Tritschler K, Basner M, Aeschbach D. Significance of time awake for predicting pilots' fatigue on short-haul flights: implications for flight duty time regulations. J Sleep Res. 2014 Oct;23(5):564-7. doi: 10.1111/jsr.12186. Epub 2014 Jul 21.

    PMID: 25040665BACKGROUND

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Erin E Flynn-Evans, PhD, MPH

CONTACT

Nicholas G Bathurst, MA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Laboratory Director

Study Record Dates

First Submitted

August 18, 2022

First Posted

September 1, 2022

Study Start

August 31, 2022

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

November 15, 2023

Record last verified: 2023-11

Locations