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Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight

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ClinicalTrials.gov Identifier: NCT03786016
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
University of Pittsburgh
National Aeronautics and Space Administration (NASA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Resilience Mood Performance Stress, Psychological Behavioral: 8-Days in an Isolation, Confinement Unit Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will be exposed to the same condition.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight: Emotional Valence and Social Processes in Isolated, Confined and Controlled Environments
Actual Study Start Date : February 22, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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.




Primary Outcome Measures :
  1. Resilience [ Time Frame: Days 1 and 8 ]
    Change in Resilience


Secondary Outcome Measures :
  1. Stress [ Time Frame: Days 1-8 ]
    Percent change in salivary cortisol

  2. Biomarker-Response to Stress [ Time Frame: Days 2, 4, 6, 8 ]
    Percent change in Brain Derived Neurotrophic Factor

  3. Brain Structure [ Time Frame: Days 1 and 8 ]
    Change in brain structure using magnetic resonance imaging (MRI)

  4. Brain Function [ Time Frame: Days 1 and 8 ]
    Change in brain function using MRI

  5. Cognitive Performance [ Time Frame: Days 2-8 ]
    Change in reaction time and accuracy using a computer-based test battery

  6. Sleep Timing and Duration [ Time Frame: Days 1-8 ]
    Continuous actigraphy recordings

  7. Heart Rate Monitoring [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786016


Contacts
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Contact: Michele Carlin 215-898-9665 michele3@pennmedicine.upenn.edu
Contact: Mathias Basner, MD, PhD 215-573-5866 basner@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michele Carlin    215-898-9665      
Sponsors and Collaborators
University of Pennsylvania
University of Pittsburgh
National Aeronautics and Space Administration (NASA)
Investigators
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Principal Investigator: David Dinges, PhD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03786016     History of Changes
Other Study ID Numbers: NASA80NSSC17K0644
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms