Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight

NCT03786016 | Completed

• 1 other identifier: NASA80NSSC17K0644
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses differences in biological and behavioral domains that relate to individual adaptation and resiliency to an isolated, confined and controlled environment, and evaluates the effect of confinement, work, monotony, and social and physical isolation on stress resiliency and well-being.

Conditions

Resilience; Mood; Performance; Stress, Psychological

Outcome Measures

Primary Outcomes (1)

• Resilience

  Change in Resilience

  Days 1 and 8

Secondary Outcomes (7)

• Stress

  Days 1-8

• Biomarker-Response to Stress

  Days 2, 4, 6, 8

• Brain Structure

  Days 1 and 8

• Brain Function

  Days 1 and 8

• Cognitive Performance

  Days 2-8

Study Arms (1)

8-Days in an Isolation, Confinement Unit

EXPERIMENTAL

Subjects will spend 7-night/8-day in an isolated and confined unit with up to 3 other subjects.

Behavioral: 8-Days in an Isolation, Confinement Unit

Interventions

8-Days in an Isolation, Confinement Unit BEHAVIORAL

Subjects will spend 8 days/7 nights continuously in an isolated and confined unit with up to 3 other subjects. Subjects will participate in daily, timed activities such as space-relevant computer simulations, team tasks, and cognitive performance testing. Subjects will also experience altered environmental conditions (such as changes in lighting, sound and ambient temperature) while in the isolation unit. Subjects will receive orders from "mission control" who will monitor activity in the isolation unit and direct subjects throughout the 8-day study.

8-Days in an Isolation, Confinement Unit

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 30 and 55 years
• A master's degree (or its equivalency in work experience) in Science, Technology, Engineering and Math (STEM) or military service
• Free of psychological/psychiatric conditions that preclude participation
• BMI \< 35
• Ability to read/write English

You may not qualify if:

• History of neurological, psychiatric, or other medical condition that excludes participation
• Current mania or psychosis
• Current depression
• Current poor resiliency
• Alcohol or drug abuse in the past year based upon history and urine toxicology screen.
• Current smoker/tobacco user.
• Acute, chronic, or debilitating medical conditions, major Axis I psychiatric illness, epilepsy, or thyroid disease based
• Cardiovascular, neurological, gastrointestinal, or musculoskeletal problems that exclude participation
• For MRI testing any of the following conditions may exclude subjects from participation in the present experiment: Tinnitus; sensorineural hearing loss \> 30 decibels; pace maker or internal defibrillator; metallic implants (e.g. orthopedic plates after bone fractures, joint replacements, surgical staples or clips, artificial heart valves, stents, cava filters); metallic splinters (e.g. after an accident or due to war injury); non-removable dental brace; tattoo (some tattoo inks contain metallic particles); permanent make-up; intrauterine contraceptive device; cochlear implant (implanted hearing device); medication pump; acupuncture needle; other foreign bodies/objects which are non-removable; pregnancy (or its possibility); previous brain and/or heart surgery; and fear of tight spaces.

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of Pittsburgh: collaborator
• National Aeronautics and Space Administration (NASA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• David Dinges, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will be exposed to the same condition.

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 24, 2018
• Study Start: February 22, 2019
• Primary Completion: December 10, 2024
• Study Completion: February 28, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)