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Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight

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University of Pennsylvania

Status

Completed

Conditions

Performance
Resilience
Mood
Stress, Psychological

Treatments

Behavioral: 8-Days in an Isolation, Confinement Unit

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT03786016
NASA80NSSC17K0644

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

30 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

8-Days in an Isolation, Confinement Unit
Experimental group
Description:
Subjects will spend 7-night/8-day in an isolated and confined unit with up to 3 other subjects.
Treatment:
Behavioral: 8-Days in an Isolation, Confinement Unit

Trial contacts and locations

1

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Central trial contact

Mathias Basner, MD, PhD; Michele Carlin

Data sourced from clinicaltrials.gov

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