AttentivU for Stress Management in Space Missions

(P-POP Trial)

Recruiting at 1 trial location

Overseen By Gary Strangman, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Neurological, psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals who may be part of future long-duration space missions and will face stressors like high workload, sleep issues, isolation, and communication delays. The study aims to help maintain optimal cognitive and behavioral functioning.

Inclusion Criteria

I am willing to participate in the study.

My vision and hearing are normal or corrected to be normal.

I can stay awake and sit still during tests.

Exclusion Criteria

Participation in a prior study associated with this protocol (due to the learning curve on some of the behavioral tests)

I have been diagnosed with a brain or mental health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform standardized tasks with and without countermeasures over 6 weeks, with psychophysiological assessments using non-invasive sensors

6 weeks

Multiple testing periods per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AttentivU

Trial Overview The AttentivU platform is being tested. It's a personalized technology that adjusts the working environment based on biosensor feedback to manage behavioral health and optimize performance in challenging conditions.

Participant Groups

Group I: Study Population Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Massachusetts Institute of Technology (MIT)

Collaborator

Trials

2

Recruited

200+