Evaluating Risk Factors and Biomarkers for Adaptation and... | NCT03786016

Studies
Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight

NCT03786016

Sponsor

University of Pennsylvania

Status

Completed

Last Update Posted

Apr 6, 2025Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Resilience
Mood
Performance
Stress, Psychological

Interventions

8-Days in an Isolation, Confinement Unit

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2019Actual

Primary Completion Date

Dec 10, 2024Actual

Completion Date

Feb 28, 2025Actual

First Submitted Date

Dec 14, 2018

First Submission Date that Met QC Criteria

Dec 21, 2018

First Posted Date

Dec 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2025

Last Update Posted Date

Apr 6, 2025Actual

Name	Class
University of Pittsburgh	OTHER
National Aeronautics and Space Administration (NASA)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Behavioral: 8-Days in an Isolation, Confinement Unit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
8-Days in an Isolation, Confinement Unit	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resilience	Change in Resilience	Days 1 and 8

Secondary Outcomes

Measure	Description	Time Frame
Stress	Percent change in salivary cortisol	Days 1-8
Biomarker-Response to Stress	Percent change in Brain Derived Neurotrophic Factor

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior