Clinical trial NCT03786016: Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight
Official title: Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight: Emotional Valence and Social Processes in Isolated, Confined and Controlled Environments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resilience
Mood
Performance
Stress, Psychological
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: National Aeronautics and Space Administration (NASA)
First posted: 2018-12-24
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be exposed to the same condition.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Resilience
timeFrame: Days 1 and 8
Secondary outcomes:
measure: Stress
timeFrame: Days 1-8
measure: Biomarker-Response to Stress
timeFrame: Days 2, 4, 6, 8
measure: Brain Structure
timeFrame: Days 1 and 8
measure: Brain Function
timeFrame: Days 1 and 8
measure: Cognitive Performance
timeFrame: Days 2-8
measure: Sleep Timing and Duration
timeFrame: Days 1-8
measure: Heart Rate Monitoring
timeFrame: Days 2, 4, 6, 8
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: David Dinges, PhD
role: PRINCIPAL_INVESTIGATOR
References: