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Sensory ScienceP-POPNCT06979570

Personalized Performance Optimization Platform

A study testing AttentivU in people with Sensory Science and Performance Assessment, run by Massachusetts General Hospital at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
What is being tested?
AttentivU
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesUnited States
Study dates
22 Feb 2021to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • MIT Media Lab

    Cambridge, Massachusetts, 02139

  • Massachusetts General Hospital

    Charlestown, Massachusetts, 02427

Other trials in United States

About this study

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

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.

Read the 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, 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. 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 the investigators 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 the investigators 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

The overall goal is to explore if one 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.

The investigators 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, the investigators hypothesize that the P-POP system's personal environment modulations (e.g., sound, haptics, light) will generate significant improvements in individuals' cognitive and operational performance.

Being tested
AttentivU
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AttentivUDevice

    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 groups in NCT06979570
Study groupRoleWhat they receive
Study PopulationExperimentalWith 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.
Receives: Device: AttentivU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 Weeks

  2. 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).

    Measured: 6 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2025
  2. Study start22 Feb 2021
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Why it stopped: The study was terminated early due to loss of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06979570
Sponsor's protocol ID
2024P003613
Other IDs
80NSSC21K0669
Acronym
P-POP
Status last verified
Mar 2026
First submitted
13 May 2025
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing AttentivU in people with Sensory Science and Performance Assessment, run by Massachusetts General Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study was terminated early due to loss of funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

N-Back Task (time frame: 6 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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