<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03786016</url>
  </required_header>
  <id_info>
    <org_study_id>NASA80NSSC17K0644</org_study_id>
    <nct_id>NCT03786016</nct_id>
  </id_info>
  <brief_title>Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight</brief_title>
  <official_title>Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight: Emotional Valence and Social Processes in Isolated, Confined and Controlled Environments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Aeronautics and Space Administration (NASA)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study assesses differences in biological and behavioral domains that relate to&#xD;
      individual adaptation and resiliency to an isolated, confined and controlled environment, and&#xD;
      evaluates the effect of confinement, work, monotony, and social and physical isolation on&#xD;
      stress resiliency and well-being.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to obtain novel information that will be used to help identify&#xD;
      individuals who are resilient to the stressors of prolonged human spaceflight, thereby&#xD;
      encouraging the successful completion of exploration missions and the preservation of health&#xD;
      over the life of an astronaut. This study leverages the National Institute of Mental Health&#xD;
      (NIMH) Research Domain Criteria (RDoC) heuristic framework to conduct experimental studies to&#xD;
      identify biological domains (molecular, circuitry, physiology) and behavioral domains that&#xD;
      relate to individual adaptation and resiliency (as well as behavioral vulnerability) in&#xD;
      spaceflight-relevant confined environments. This study focuses specifically on differences&#xD;
      among participants in their tolerance of and adaptability to simulated conditions of&#xD;
      spaceflight such as confinement, work, monotony, and social/physical isolation that impact&#xD;
      behavioral health and performance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 22, 2019</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All participants will be exposed to the same condition.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resilience</measure>
    <time_frame>Days 1 and 8</time_frame>
    <description>Change in Resilience</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>Days 1-8</time_frame>
    <description>Percent change in salivary cortisol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker-Response to Stress</measure>
    <time_frame>Days 2, 4, 6, 8</time_frame>
    <description>Percent change in Brain Derived Neurotrophic Factor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain Structure</measure>
    <time_frame>Days 1 and 8</time_frame>
    <description>Change in brain structure using magnetic resonance imaging (MRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain Function</measure>
    <time_frame>Days 1 and 8</time_frame>
    <description>Change in brain function using MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Performance</measure>
    <time_frame>Days 2-8</time_frame>
    <description>Change in reaction time and accuracy using a computer-based test battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Timing and Duration</measure>
    <time_frame>Days 1-8</time_frame>
    <description>Continuous actigraphy recordings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Monitoring</measure>
    <time_frame>Days 2, 4, 6, 8</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Resilience</condition>
  <condition>Mood</condition>
  <condition>Performance</condition>
  <condition>Stress, Psychological</condition>
  <arm_group>
    <arm_group_label>8-Days in an Isolation, Confinement Unit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will spend 7-night/8-day in an isolated and confined unit with up to 3 other subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>8-Days in an Isolation, Confinement Unit</intervention_name>
    <description>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 &quot;mission control&quot; who will monitor activity in the isolation unit and direct subjects throughout the 8-day study.</description>
    <arm_group_label>8-Days in an Isolation, Confinement Unit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 30 and 55 years&#xD;
&#xD;
          -  A master's degree (or its equivalency in work experience) in Science, Technology,&#xD;
             Engineering and Math (STEM) or military service&#xD;
&#xD;
          -  Free of psychological/psychiatric conditions that preclude participation&#xD;
&#xD;
          -  BMI &lt; 35&#xD;
&#xD;
          -  Ability to read/write English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of neurological, psychiatric, or other medical condition that excludes&#xD;
             participation&#xD;
&#xD;
          -  Current mania or psychosis&#xD;
&#xD;
          -  Current depression&#xD;
&#xD;
          -  Current poor resiliency&#xD;
&#xD;
          -  Alcohol or drug abuse in the past year based upon history and urine toxicology screen.&#xD;
&#xD;
          -  Current smoker/tobacco user.&#xD;
&#xD;
          -  Acute, chronic, or debilitating medical conditions, major Axis I psychiatric illness,&#xD;
             epilepsy, or thyroid disease based&#xD;
&#xD;
          -  Cardiovascular, neurological, gastrointestinal, or musculoskeletal problems that&#xD;
             exclude participation&#xD;
&#xD;
          -  For MRI testing any of the following conditions may exclude subjects from&#xD;
             participation in the present experiment: Tinnitus; sensorineural hearing loss &gt; 30 dB;&#xD;
             pace maker or internal defibrillator; metallic implants (e.g. orthopedic plates after&#xD;
             bone fractures, joint replacements, surgical staples or clips, artificial heart&#xD;
             valves, stents, cava filters); metallic splinters (e.g. after an accident or due to&#xD;
             war injury); non-removable dental brace; tattoo (some tattoo inks contain metallic&#xD;
             particles); permanent make-up; intrauterine contraceptive device; cochlear implant&#xD;
             (implanted hearing device); medication pump; acupuncture needle; other foreign&#xD;
             bodies/objects which are non-removable; pregnancy (or its possibility); previous brain&#xD;
             and/or heart surgery; and fear of tight spaces.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Dinges, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michele Carlin</last_name>
    <phone>215-898-9665</phone>
    <email>michele3@pennmedicine.upenn.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mathias Basner, MD, PhD</last_name>
    <phone>215-573-5866</phone>
    <email>basner@pennmedicine.upenn.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michele Carlin</last_name>
      <phone>215-898-9665</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786016
org study id: NASA80NSSC17K0644
nct id: NCT03786016
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All participants will be exposed to the same condition.
primary purpose: Other
masking: None (Open Label)
measure: Resilience
time frame: Days 1 and 8
description: Change in Resilience
measure: Stress
time frame: Days 1-8
description: Percent change in salivary cortisol
measure: Biomarker-Response to Stress
time frame: Days 2, 4, 6, 8
description: Percent change in Brain Derived Neurotrophic Factor
measure: Brain Structure
time frame: Days 1 and 8
description: Change in brain structure using magnetic resonance imaging (MRI)
measure: Brain Function
time frame: Days 1 and 8
description: Change in brain function using MRI
measure: Cognitive Performance
time frame: Days 2-8
description: Change in reaction time and accuracy using a computer-based test battery
measure: Sleep Timing and Duration
time frame: Days 1-8
description: Continuous actigraphy recordings
measure: Heart Rate Monitoring
time frame: Days 2, 4, 6, 8
description: 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.
arm group label: 8-Days in an Isolation, Confinement Unit
arm group type: Experimental
description: Subjects will spend 7-night/8-day in an isolated and confined unit with up to 3 other subjects.
intervention type: Behavioral
intervention name: 8-Days in an Isolation, Confinement Unit
description: 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.
arm group label: 8-Days in an Isolation, Confinement Unit
criteria: 
gender: All
minimum age: 30 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Dinges, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Michele Carlin
phone: 215-898-9665
email: michele3@pennmedicine.upenn.edu
last name: Mathias Basner, MD, PhD
phone: 215-573-5866
email: basner@pennmedicine.upenn.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Stress, Psychological
sharing ipd: No