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临床试验/NCT06979570
NCT06979570招募中不适用

Personalized Performance Optimization Platform (P-POP) for Long Duration Spaceflight

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
N-Back Task

研究概览

简要总结

Crews of future long-duration exploration missions will have to cope with a wide range of stressors that present significant challenges for maintaining optimal performance. Crews will have to operate under conditions of high workload, reduced sleep and circadian dysregulation, limited sensory stimulation, confinement and extended separation from family and friends, and communication delays isolating them from real-time interaction with ground support, which may be particularly critical in the event of emergencies. These factors present significant risks to optimal cognitive/behavioral functioning and performance, across individuals and teams, and such challenges will only increase in criticality as human exploration moves beyond Earth's orbit to targets such as the Moon and Mars. To help mitigate these risks, Massachusetts General Hospital, along with collaborators at the Massachusetts Institute of Technology, will investigate a novel, personalized and scalable, closed-loop platform technology for on-board behavioral health management-one which adapts the local working environment to optimize performance based on biosensor feedback.

详细描述

  1. Background and Significance

Crews of future long-duration space exploration missions will have to cope with a wide range of stressors that present significant challenges for maintaining optimal performance. Crews will have to operate under conditions of high workload, reduced sleep and circadian dysregulation, limited sensory stimulation, confinement and extended separation from family and friends [5], and communication delays isolating them from real-time interaction with ground support, which may be particularly critical in the event of emergencies. These factors present significant risks to optimal cognitive/behavioral functioning and performance, across individuals and teams, and such challenges will only increase in criticality as human exploration moves beyond Earth's orbit to targets such as the Moon and Mars.

To help mitigate these risks, Massachusetts General Hospital, along with collaborators at the Massachusetts Institute of Technology, will investigate a novel, personalized and scalable, closed-loop platform technology for on-board behavioral health management-one which adapts an individual's local working environment to optimize performance, based on biosensor feedback.

Countermeasures (CMs) to Maintain/Improve Performance The premise of this proposed work is dynamically modifying an individual's local environment to help optimize performance. Since video displays require complex electronics which may not function in deep space, the investigators will study the following non-video countermeasures (CMs).

Auditory Stimulation: Acoustic cues are common in biofeedback systems, with beeps and chimes often used to help trigger attentional redirection. Other sound cues-including natural sounds like flowing water, or even music-can also induce performance-beneficial physiological responses, including predictable changes in arousal-related measures such as heart rate and EDA. The underlying beat of music has been shown to alter arousal, with different modulations promoting relaxation or increased attention. Previous work also suggests that music may impact complex task performance (e.g., driving), and may alter student learning, through its mediating effects on arousal and alertness.

研究设计

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

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Willingness to participate in the study
  • •Must be between the ages of 18 to 64
  • •Normal or corrected-to-normal vision and hearing
  • •Ability to sit still and stay awake during the experimental sessions

排除标准

  • •Diagnosis with Neurological or psychiatric disorder
  • •Participation in a prior study associated with this protocol (due to the learning- curve on some of the behavioral tests)

研究组 & 干预措施

Study Population

Experimental

With multiple testing periods per week over the course of 6 weeks. Participants will perform the standardized tasks both with and without deployment of the countermeasure during this period. Psychophysiological assessment and countermeasure deployment will be conducted with non-invasive sensors for physiological monitoring and non-invasive effectors.

干预措施: AttentivU (Device)

结局指标

主要结局

N-Back Task

时间窗: 6 Weeks

A cognitive assessment designed to measure working memory speed and accuracy. During the task, participants are presented with a sequence of stimuli (letters, numbers, or spatial locations) and must indicate whether the current stimulus matches the one presented earlier. Performance is assessed through reaction time, accuracy, and response variability, providing insight into both cognitive processing speed and working memory capacity.

Psychomotor Vigilance Test (PVT)

时间窗: 6 Weeks

A Validated neurobehavioral assessment of sustained attention and reaction time performance. The task measures the participant's ability to detect and respond to a visual stimulus, typically a randomly-timed cue presented on a screen. Key outcome measures include mean reaction time, lapses (responses exceeding a defined threshold, typically 500 ms), and false starts (premature responses).

次要结局

未报告次要终点

研究者

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

Gary E. Strangman

Principle Investigator

Massachusetts General Hospital

研究点 (2)

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