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Completed

NCT Number: NCT03786016

Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight

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.

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Key information

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

The goal of this study is to obtain novel information that will be used to help identify individuals who are resilient to the stressors of prolonged human spaceflight, thereby encouraging the successful completion of exploration missions and the preservation of health over the life of an astronaut. This study leverages the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) heuristic framework to conduct experimental studies to identify biological domains (molecular, circuitry, physiology) and behavioral domains that relate to individual adaptation and resiliency (as well as behavioral vulnerability) in spaceflight-relevant confined environments. This study focuses specifically on differences among participants in their tolerance of and adaptability to simulated conditions of spaceflight such as confinement, work, monotony, and social/physical isolation that impact behavioral health and performance.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Resilience

    Time frame: Days 1 and 8

    Change in Resilience

Secondary outcomes

  1. Stress

    Time frame: Days 1-8

    Percent change in salivary cortisol

  2. Biomarker-Response to Stress

    Time frame: Days 2, 4, 6, 8

    Percent change in Brain Derived Neurotrophic Factor

  3. Brain Structure

    Time frame: Days 1 and 8

    Change in brain structure using magnetic resonance imaging (MRI)

  4. Brain Function

    Time frame: Days 1 and 8

    Change in brain function using MRI

  5. Cognitive Performance

    Time frame: Days 2-8

    Change in reaction time and accuracy using a computer-based test battery

  6. Sleep Timing and Duration

    Time frame: Days 1-8

    Continuous actigraphy recordings

  7. Heart Rate Monitoring

    Time frame: Days 2, 4, 6, 8

    24 h ECG data will be collected to derive heart rate (HR) and heart rate variability (HRV) measures as a peripheral index of vagal balance.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Aeronautics and Space Administration (NASA)
  • University of Pittsburgh

Registry information

Official study title

Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight: Emotional Valence and Social Processes in Isolated, Confined and Controlled Environments

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Dec 24, 2018
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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