Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03786016
• Other study ID #: NASA80NSSC17K0644
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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 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.

Related Conditions & MeSH terms

• Mood
• Performance
• Resilience
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	National Aeronautics and Space Administration (NASA), University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

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