Clinical trial NCT06979570: Personalized Performance Optimization Platform
Official title: Personalized Performance Optimization Platform (P-POP) for Long Duration Spaceflight
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sensory Science
Performance Assessment
Countermeasure Evaluation
Neurocognitive Function
Psychological Factors
Keywords: Long-Duration Spaceflight
Cogntiive Performance
Wearable Biosensors
Closed-Loop Systems
Auditory Stimulation
Haptic Feedback
Light Modulation
Psychophysiological Monitoring
Sensorimotor Performance
Behavioral Health Management
Attention Optimization
Stress Reduction
Fatigue Management
Cognitive Load
Environmental Modulations
Performance Enhancement
Non-Invasive Sensors
Adaptive Techology
Personalized Feedback
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology (MIT)
First posted: 2025-05-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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, we will investigate 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.

   Haptic Stimulation: Haptic feedback-via vibration, touch, or electrical stimulation-can be administered through individual or coordinated arrays of actuators. Prior research shows that the body location of a vibrotactile device can determine stimulation effectiveness, with the back, neck, and wrist/forearm areas presenting particularly sensitive sites for pressure and vibration-based alerting. Rhythm, roughness, intensity, and frequency can also be altered optimize vibrotactile display design. Such haptic cues have previously proven effective in redirecting attention to promote user engagement during a task, as well as improving coordinated motor performance (e.g., ambulation and postural sway).

   Light Stimulation: Lighting brightness, intensity, and color all impact information processing. The chronobiological influence of blue light as a circadian pacemaker, for example, has been well established. Increasing light brightness has been shown to promote alertness, and color can strongly influence alertness as well as mood / emotional processing, with certain colors (e.g., green) being useful in the modulation of autonomic arousal. The frequency of light flickering can also affect behavioral performance, with 40Hz light flickering supporting increased attention/arousal, and 10Hz flickering supporting reduced arousal.

   Knowledge Gaps: The above prior findings demonstrate that modulations of auditory, haptic, and light stimuli can each produce reliable changes in neurocognitive and psychological state (e.g., arousal, attention) related to performance. However, limited work has been done to establish a direct connection between environmental augmentations and performance changes, and we are not aware of any studies specifically targeting operationally-relevant (i.e., complex task) behavioral performance.

   Purpose: The purpose of the study is to explore if we can reliably detect, measure and provide feedback to users to optimize their cognitive states using wearable devices that measure their brain activity and other physiological signals, with the goal of improving behavioral task performance.

   Study endpoints: Change in the user's performance level (enhancements or decrements) while performing experimental tasks.

   Study Structure: These studies will be conducted at MIT-which is a subcontract under the MGH (=prime) award from NASA (prime PI=Dr. Gary Strangman)-by the MIT investigators, with design and analysis support from the MGH investigators. All data collected-in de-identified, coded form only-will be transmitted to Dr. Strangman at MGH (via secure transfer.partners.org) for additional analysis and to implement the required data sharing back to NASA. MGH personnel will not have access to the coding key.
2. Specific Aims and Objectives

Our overall goal is to explore if we can (1) reliably measure physiological signals to detect person's cognitive states such as attention, fatigue, cognitive load and stress, and (2) provide the feedback to the user to help improve behavioral states, questionnaires, and/or users' overall performance.

We will quantify performance changes associated with simple sensory manipulations in both cognitive tasks and tasks that are relevant to spaceflight operations. Tasks will include a battery of cognitive tests as well as tasks that are operationally-relevant to NASA. Environmental manipulations will seek to maintain optimal attention, engagement, cognitive load, and alertness, as assessed by psychophysiological signatures.

Aim 1: Assess behavioral changes associated with auditory-based manipulations. Aim 2: Assess behavioral changes associated with haptic-based manipulations. Aim 3: Assess behavioral changes associated with light-based manipulations.

Hypotheses: For each Aim, we hypothesize that our P-POP system's personal environment modulations (e.g., sound, haptics, light) will generate significant improvements in individuals' cognitive and operational performance.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: N-Back Task
timeFrame: 6 Weeks
measure: Psychomotor Vigilance Test (PVT)
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: MIT Media Lab
state: Massachusetts
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: