NCT07761611

Brief Summary

The purpose of the present study is to test novel countermeasures to reduce fatigue among airline pilots during long-haul flight operations. The investigators will collect objective and subjective sleep, sleepiness, workload, and performance data from active-duty line pilots flying long-haul flight operations (\>8 hours). Data will be collected during days off prior to the trip start, during flights and layover, and during days off following the trip end.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
34mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

July 10, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

2.8 years

First QC Date

July 10, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

fatiguealertnesscognitive performancelight interventioncalorie restrictionaviationpsychomotor vigilance taskNASA TLX

Outcome Measures

Primary Outcomes (4)

  • Vigilant Attention

    Measured using the 5-minute Psychomotor Vigilance Task (PVT); a simple reaction time test with measures that include mean reaction time, response speed (1/RT), and number of lapses (RT \> 500ms).

    minimum of 18 days, morning, afternoon, evening and top of descent of all flights

  • Subjective Sleepiness

    Measured using the Karolinska Sleepiness Scale (KSS); a 9-point Likert scale with higher scores indicating higher levels of sleepiness.

    Minimum of 18 days, morning, afternoon, evening and top of descent of all flights

  • Subjective Fatigue

    Measured using the Samn-Perelli fatigue scale; a 7-point Likert scale with higher scores indicating higher levels of fatigue

    minimum of 18 days, morning, afternoon, evening and top of descent of all flights

  • Objective Sleep

    Measured using an accelerometer (wristwatch-like device) and light sensor to determine sleep and wake patterns and various other objective sleep metrics (e.g., sleep onset, wake after sleep onset, total sleep time).

    24 hours a day for a minimum of 18 days

Study Arms (2)

Intervention (caloric restriction and light intervention)

EXPERIMENTAL

The intervention will involve asking pilots to reduce their calorie intake during the biological night to \< 10% of their daily need and to wear blue-enriched light emitting glasses for 20 minutes following their inflight rest break before they return to the flight deck during both outbound and return flights

Behavioral: Caloric restrictionDevice: Light exposure

Control

NO INTERVENTION

The control condition will involve reminding pilots about standard fatigue risk management practices that are recommended by their company.

Interventions

To reduce calorie intake during the biological night to \< 10% of calculated daily need.

Intervention (caloric restriction and light intervention)

To wear blue-enriched light emitting glasses for 20 minutes following an inflight rest break before returning to the flight deck during both outbound and return flights.

Intervention (caloric restriction and light intervention)

Eligibility Criteria

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

You may qualify if:

  • All medically qualified, active-duty pilots currently flying overnight long-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 long-haul operations (defined at flights over eight hours induration).

You may not qualify if:

  • Pilots with metabolic disorders, such as diabetes, those actively trying to lose weight or receiving GLP-1 injections, or those who indicate that they are sensitive to light will be excluded from participation. The medical monitor will review the pilot's self-reported medical conditions and medications (if applicable) prior to enrolment in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NASA Ames Research Center

Mountain View, California, 94043, United States

Location

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MeSH Terms

Conditions

Fatigue

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Erin E Flynn-Evans, PhD, MPH

CONTACT

Nicholas G Bathurst, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomized to receive the intervention or control. The intervention will involve asking pilots to reduce their calorie intake during the biological night to \< 10% of their daily need and to wear blue-enriched light emitting glasses for 20 minutes following their inflight rest break before they return to the flight deck during both outbound and return flights. Participants in the intervention condition will also be asked to refrain from eating during the biological night during the three pre-trip nights. The control condition will involve reminding pilots about standard fatigue risk management practices that are recommended by their company. This will be a between-subjects, rather than within-subjects study to minimize intervention spillover. Participants will collect data for two trips, with the first trip representing a baseline for each collection.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Laboratory Director

Study Record Dates

First Submitted

July 10, 2026

First Posted

August 12, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

August 12, 2026

Record last verified: 2026-08

Locations