Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight

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

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.

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Performance; Resilience; Mood
• Intervention / Treatment: Behavioral: 8-Days in an Isolation, Confinement Unit

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 8-Days in an Isolation, Confinement Unit; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resilience	Change in Resilience	Days 1 and 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress	Percent change in salivary cortisol	Days 1-8
Biomarker-Response to Stress	Percent change in Brain Derived Neurotrophic Factor	Days 2, 4, 6, 8
Brain Structure	Change in brain structure using magnetic resonance imaging (MRI)	Days 1 and 8
Brain Function	Change in brain function using MRI	Days 1 and 8
Cognitive Performance	Change in reaction time and accuracy using a computer-based test battery	Days 2-8
Sleep Timing and Duration	Continuous actigraphy recordings	Days 1-8
Heart Rate Monitoring	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.	Days 2, 4, 6, 8

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: University of Pittsburgh; National Aeronautics and Space Administration (NASA)
• Investigators: Principal Investigator: David Dinges, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2019
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: NASA80NSSC17K0644

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No