Back to resultsEvaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight
Primary Purpose
Resilience, Mood, Performance
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
8-Days in an Isolation, Confinement Unit
Sponsored by
About this trial
This is an interventional other trial for Resilience
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 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.
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
8-Days in an Isolation, Confinement Unit
Arm Description
Subjects will spend 7-night/8-day in an isolated and confined unit with up to 3 other subjects.
Outcomes
Primary Outcome Measures
Resilience
Change in Resilience
Secondary Outcome Measures
Stress
Percent change in salivary cortisol
Biomarker-Response to Stress
Percent change in Brain Derived Neurotrophic Factor
Brain Structure
Change in brain structure using magnetic resonance imaging (MRI)
Brain Function
Change in brain function using MRI
Cognitive Performance
Change in reaction time and accuracy using a computer-based test battery
Sleep Timing and Duration
Continuous actigraphy recordings
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.
Full Information
NCT ID
NCT03786016
First Posted
December 14, 2018
Last Updated
October 3, 2023
Sponsor
University of Pennsylvania
Collaborators
University of Pittsburgh, National Aeronautics and Space Administration (NASA)
1. Study Identification
Unique Protocol Identification Number
NCT03786016
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
University of Pittsburgh, National Aeronautics and Space Administration (NASA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resilience, Mood, Performance, Stress, Psychological
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will be exposed to the same condition.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
8-Days in an Isolation, Confinement Unit
Arm Type
Experimental
Arm 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(s)
8-Days in an Isolation, Confinement Unit
Intervention 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.
Primary Outcome Measure Information:
Title
Resilience
Description
Change in Resilience
Time Frame
Days 1 and 8
Secondary Outcome Measure Information:
Title
Stress
Description
Percent change in salivary cortisol
Time Frame
Days 1-8
Title
Biomarker-Response to Stress
Description
Percent change in Brain Derived Neurotrophic Factor
Time Frame
Days 2, 4, 6, 8
Title
Brain Structure
Description
Change in brain structure using magnetic resonance imaging (MRI)
Time Frame
Days 1 and 8
Title
Brain Function
Description
Change in brain function using MRI
Time Frame
Days 1 and 8
Title
Cognitive Performance
Description
Change in reaction time and accuracy using a computer-based test battery
Time Frame
Days 2-8
Title
Sleep Timing and Duration
Description
Continuous actigraphy recordings
Time Frame
Days 1-8
Title
Heart Rate Monitoring
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.
Time Frame
Days 2, 4, 6, 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Dinges, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight
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