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临床试验/NCT03786016
NCT03786016已完成不适用

Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight: Emotional Valence and Social Processes in Isolated, Confined and Controlled Environments

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Resilience

研究概览

简要总结

This study assesses differences in biological and behavioral domains that relate to individual adaptation and resiliency to an isolated, confined and controlled environment, and evaluates the effect of confinement, work, monotony, and social and physical isolation on stress resiliency and well-being.

详细描述

The goal of this study is to obtain novel information that will be used to help identify individuals who are resilient to the stressors of prolonged human spaceflight, thereby encouraging the successful completion of exploration missions and the preservation of health over the life of an astronaut. This study leverages the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) heuristic framework to conduct experimental studies to identify biological domains (molecular, circuitry, physiology) and behavioral domains that relate to individual adaptation and resiliency (as well as behavioral vulnerability) in spaceflight-relevant confined environments. This study focuses specifically on differences among participants in their tolerance of and adaptability to simulated conditions of spaceflight such as confinement, work, monotony, and social/physical isolation that impact behavioral health and performance.

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
30 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 30 and 55 years
  • A master's degree (or its equivalency in work experience) in Science, Technology, Engineering and Math (STEM) or military service
  • Free of psychological/psychiatric conditions that preclude participation
  • BMI < 35
  • Ability to read/write English

排除标准

  • History of neurological, psychiatric, or other medical condition that excludes participation
  • Current mania or psychosis
  • Current depression
  • Current poor resiliency
  • Alcohol or drug abuse in the past year based upon history and urine toxicology screen.
  • Current smoker/tobacco user.
  • Acute, chronic, or debilitating medical conditions, major Axis I psychiatric illness, epilepsy, or thyroid disease based
  • Cardiovascular, neurological, gastrointestinal, or musculoskeletal problems that exclude participation
  • For MRI testing any of the following conditions may exclude subjects from participation in the present experiment: Tinnitus; sensorineural hearing loss > 30 decibels; pace maker or internal defibrillator; metallic implants (e.g. orthopedic plates after bone fractures, joint replacements, surgical staples or clips, artificial heart valves, stents, cava filters); metallic splinters (e.g. after an accident or due to war injury); non-removable dental brace; tattoo (some tattoo inks contain metallic particles); permanent make-up; intrauterine contraceptive device; cochlear implant (implanted hearing device); medication pump; acupuncture needle; other foreign bodies/objects which are non-removable; pregnancy (or its possibility); previous brain and/or heart surgery; and fear of tight spaces.

结局指标

主要结局

Resilience

时间窗: Days 1 and 8

Change in Resilience

次要结局

  • Stress(Days 1-8)
  • Biomarker-Response to Stress(Days 2, 4, 6, 8)
  • Brain Structure(Days 1 and 8)
  • Cognitive Performance(Days 2-8)
  • Brain Function(Days 1 and 8)
  • Sleep Timing and Duration(Days 1-8)
  • Heart Rate Monitoring(Days 2, 4, 6, 8)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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