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临床试验/NCT01744678
NCT01744678已完成不适用

Experimental Trial of Fatigue Countermeasure Program in Operational Flight Controllers

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Alertness/Fatigue as measured by Psychomotor Vigilance Task and Visual Analog Scales

研究概览

简要总结

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. 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. 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. 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. 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. 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.

详细描述

Each participant will have three data collection periods. Each data collection period will last one shift rotation (5 -7 days): One 5-shift or 7-shift block of Orbit 1 night shifts on console with access to photic and exercise countermeasures, a second 5-shift or 7-shift block of Orbit 1 night shifts on console with no access to countermeasures, and a third 5-shift block of daytime office work off console. We will be measuring sleep via a wrist worn activity measuring device and compliance of exercise intervention via a small, commercially available heart monitor worn around the chest underneath clothing. The activity device will be worn continuously and the heart monitor will be worn on shift. These devices will be downloaded at the end of each block of shifts. Subjects will complete a short baseline questionnaire once at the beginning of the study. Subjective alertness will be assessed with the Karolinska Sleepiness Scale (KSS), performance testing will occur regularly and 'end of shift' questionnaires will be completed at the end of each shift. Drowsiness will be measured on the commute to and from work with the Optalert.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: blue-wavelength enriched ceiling light (Behavioral)

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.

干预措施: mild exercise (Behavioral)

结局指标

主要结局

Alertness/Fatigue as measured by Psychomotor Vigilance Task and Visual Analog Scales

时间窗: Three weeks.

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)

次要结局

  • Sleep duration as measured by wrist actigraphy(Three weeks.)
  • Sleep duration as captured in sleep/work logs(Three weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charles Andrew Czeisler, MD, PhD

Chief, Division of Sleep Medicine

Brigham and Women's Hospital

研究点 (2)

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