Personalized Performance Optimization Platform

NCT06979570 | Terminated

• 2 other identifiers: 2024P00361380NSSC21K0669
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Neurocognitive Function; Psychological Factors; Countermeasure Evaluation; Sensory Science; Performance Assessment

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

Outcome Measures

Primary Outcomes (2)

• N-Back Task

  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.

  6 Weeks

• Psychomotor Vigilance Test (PVT)

  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).

  6 Weeks

Study Arms (1)

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.

Device: AttentivU

Interventions

AttentivU DEVICE

A device for continuous brain and physiology monitoring. It includes up to 8 EEG sensors as well as EOG and accelerometry which can be monitored in real-time for changes in attention, sleepiness, alertness, cognitive load, stress, and related psychological traits. The EEG data is analyzed in real-time to identify these states and this information can then be used to modulate "countermeasures" to the state--to either increase or decrease alertness or help counteract cognitive load sleepiness or stress conditions.

Study Population

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts Institute of Technology (MIT): collaborator
• Massachusetts General Hospital: lead

Study Sites (2)

MIT Media Lab

Cambridge, Massachusetts, 02139, United States

Location

Massachusetts General Hospital

Charlestown, Massachusetts, 02427, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: February 22, 2021
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (2)