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临床试验/NCT05524441
NCT05524441招募中不适用

Evaluation of Fatigue in Short-Haul Operations Across Multiple Airlines

Civil Aerospace Medical Institute1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2022年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
204
试验地点
1
主要终点
Vigilant Attention

研究概览

简要总结

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.

详细描述

Protocol Summary. The investigators will collect objective and subjective sleep, sleepiness, workload, and performance data from on-duty pilots during the aforementioned 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. Each participant will collect data during two trips lasting 2-7 days each, with up to 3 days of off-duty data collection before and after each trip, for a total data collection of up to 26 days per pilot.

Study Aims. The goal of this study is to provide insight into the influence of trips including circadian disruption on pilot cognitive performance, fatigue, sleepiness, sleep, and workload during short-haul operations across multiple airlines.

Hypothesis. Cognitive performance, fatigue, sleepiness, and sleep outcomes will be worse during circadian disrupted trips compared to trips that do not involve circadian disruption.

Statistical Analyses. The following factors will be also considered for inclusion in the analysis:

  • Schedule features: flight duration, duty duration, duty start and finish times
  • Individual factors: age, experience, chronotype (as measured by the morningness-eveningness questionnaire), sleep need
  • Sleep: sleep duration, sleep loss, sleep start and finish times (all measured by the actiwatch)
  • Fatigue/alertness: pre- and post-sleep and on-duty fatigue and alertness ratings (as measured by subjective scales)
  • Workload: hassle factors encountered during flights and NASA TLX

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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).
  • 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.

排除标准

  • No additional exclusion criteria

结局指标

主要结局

Vigilant Attention

时间窗: up to 26 days

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))

Sleep

时间窗: up to 26 days

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

Fatigue/alertness

时间窗: up to 26 days

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.

次要结局

未报告次要终点

研究者

发起方
Civil Aerospace Medical Institute
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Erin E. Flynn-Evans

Laboratory Director

National Aeronautics and Space Administration (NASA)

研究点 (1)

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