Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight

Not Applicable

Active, not recruiting

• Conditions: Performance; Resilience; Mood; Stress, Psychological
• Interventions: Behavioral: 8-Days in an Isolation, Confinement Unit

• Registration Number: NCT03786016
• Lead Sponsor: University of Pennsylvania

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.

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 Timeline

• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-24
• Study Start: 2019-02-22
• Status Verified: 2024-12
• Primary Completion: 2024-12-10
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Read More

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 dB; 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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
8-Days in an Isolation, Confinement Unit	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.

Primary Outcome Measures

Name	Time	Method
Resilience	Days 1 and 8	Change in Resilience

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States