ResilienceNCT03786016
Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight
A study testing 8-Days in an Isolation, Confinement Unit in people with Resilience and Mood, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Resilience, Mood, Performance
- What is being tested?
- 8-Days in an Isolation, Confinement Unit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2019to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight: Emotional Valence and Social Processes in Isolated, Confined and Controlled Environments
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.
Read the 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.
- Conditions
- Resilience, Mood, Performance, Stress, Psychological
- Being tested
- 8-Days in an Isolation, Confinement Unit
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-Days in an Isolation, Confinement UnitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 8-Days in an Isolation, Confinement Unit | Experimental | Subjects will spend 7-night/8-day in an isolated and confined unit with up to 3 other subjects. Receives: Behavioral: 8-Days in an Isolation, Confinement Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience
Change in Resilience
Measured: Days 1 and 8
Secondary outcomes (7)
Stress
Percent change in salivary cortisol
Measured: Days 1-8
Biomarker-Response to Stress
Percent change in Brain Derived Neurotrophic Factor
Measured: Days 2, 4, 6, 8
Brain Structure
Change in brain structure using magnetic resonance imaging (MRI)
Measured: Days 1 and 8
Brain Function
Change in brain function using MRI
Measured: Days 1 and 8
Cognitive Performance
Change in reaction time and accuracy using a computer-based test battery
Measured: Days 2-8
Sleep Timing and Duration
Continuous actigraphy recordings
Measured: Days 1-8
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.
Measured: Days 2, 4, 6, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start22 Feb 2019
- Primary completion10 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResilienceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be exposed to the same condition.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, National Aeronautics and Space Administration (NASA)
- Responsible party
- Sponsor
- Investigators
- David Dinges, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786016
- Sponsor's protocol ID
- NASA80NSSC17K0644
- Status last verified
- Apr 2025
- First submitted
- 14 Dec 2018
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight: Emotional Valence and Social Processes in Isolated, Confined and Controlled Environments
- ClinicalTrials.gov ID
- NCT03786016
- Acronym / sponsor ID
- NASA80NSSC17K0644
- Conditions
- Resilience, Mood, Performance, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Pittsburgh, National Aeronautics and Space Administration (NASA)
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be exposed to the same condition.
| Arm | Type | Receives |
|---|---|---|
| 8-Days in an Isolation, Confinement Unit | Experimental | Behavioral: 8-Days in an Isolation, Confinement UnitSubjects will spend 7-night/8-day in an isolated and confined unit with up to 3 other subjects. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8-Days in an Isolation, Confinement UnitSubjects 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. | Behavioural | 8-Days in an Isolation, Confinement Unit |
Primary outcome
Resilience
Time frame: Days 1 and 8
Change in Resilience
7 secondary outcomes
Stress
Time frame: Days 1-8
Biomarker-Response to Stress
Time frame: Days 2, 4, 6, 8
Brain Structure
Time frame: Days 1 and 8
Brain Function
Time frame: Days 1 and 8
Cognitive Performance
Time frame: Days 2-8
Sleep Timing and Duration
Time frame: Days 1-8
Heart Rate Monitoring
Time frame: Days 2, 4, 6, 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Dinges, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-Days in an Isolation, Confinement Unit in people with Resilience and Mood, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience (time frame: Days 1 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.