Recruiting

Fatigue

Sponsor:

Civil Aerospace Medical Institute

Code:

NCT05524441

Conditions

Fatigue

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Circadian Disruption - Quasi-Experimental

Study Details

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.

Conditions

Fatigue

Study ID

NCT05524441

Start date

Aug 31, 2022

Status verified date

Nov, 2023

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. 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.

OR

• 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
2. 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.

Exclusion Criteria:

  • No additional exclusion criteria

Study Design

Enrollment

204 participants

Anticipated

Interventions and Outcome Measures

Arms

Airline 1

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

Airline 2

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

Airline 3

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

Airline 4

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

Interventions

Circadian Disruption - Quasi-Experimental

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

Primary outcome measure

  • Vigilant Attention [ Time Frame: up to 26 days ]
  • Sleep [ Time Frame: up to 26 days ]
  • Fatigue/alertness [ Time Frame: up to 26 days ]

Central Contacts and Locations

Central contacts

Erin E Flynn-Evans, PhD, MPH

6502793459erin.e.flynn-evans@nasa.gov

Nicholas G Bathurst, MA

4083484075nicholas.g.bathurst@nasa.gov

Locations

NASA Ames Research Center

Recruiting

Mountain View, California, United States, 94043

Contacts

Erin E Flynn-Evans, PhD, MPH

erin.e.flynn-evans@nasa.gov

Nicholas G Bathurst, MA

nicholas.g.bathurst@nasa.gov

More Information

Sponsor

Civil Aerospace Medical Institute

Last update posted

Nov 15, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Civil Aerospace Medical Institute on 2023-11-15.