Body-environment Relationship Related Modified Gravity

Study Overview
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Brief Summary
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The overall objective of this study is to better understand the relationship between the body and its environment, including cognitive performance, following repeated changes in gravity, including microgravity (0G) and modified gravity (i.e., hypergravity (1.8G) and modified gravity (Martian gravity)

Detailed Description
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On the eve of the next long voyages into space and the event of space tourism, it becomes more and more urgent to understand how to preserve the health of spacemen (i.e., by profession or by leisure). Extreme and unusual environments, and isolated and confined environments (EUE/ICE) are characterized by unique sensory stimulation. They are known to have negative effects on human psychology, cognitive abilities and physiology, threatening the outcome of space missions or travel. In addition, with the construction of the future Gateway base, the upcoming colonies to Mars and space tourism, travel from one point to another will be much more frequent. These raise new questions that will have to be addressed, whether it is the prolonged duration of a stay in a microgravity environment (i.e., absence of gravitational force between man and his support), in partial gravity and thus the issue of recovery from one trip to the next. These modifications of the environment imply the implementation of several adaptation processes to preserve the homeostatic capacity of the organism. This allows the organism to maintain a relatively stable internal state that persists despite external changes. Nevertheless, many questions remain unanswered. One such question is the impact of repeated changes in gravity during flight to the point of attachment (e.g., colony). The objective of the study is therefore to better understand the relationship between the body and its environment due to repeated changes in gravity, including microgravity. Beyond that, these results will contribute to enrich the knowledge of this real human challenge that is the question of the adaptation of the human being to the constraints of space travel.

Official Title
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Repetitive Gravitationnal Changes on the Body-environment Relationship

Conditions
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Body Schema

Intervention / Treatment
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* Other: Cognition and emotional neuropsychologicl evaluations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Existence of an informed and written consent from the subject Not pregnant No anxiety disorder and/or depression Not to have suffered a head injury Have obtained a medical certificate of aptitude for parabolic flights Be affiliated to the French Social Security, or have a European Health Insurance Card or equivalent Exclusion Criteria: Pregnant women, parturients and nursing mothers Endocrine pathology (e.g., hyperthyroidism, diabetes) High blood pressure History of head trauma, mood or cardiovascular disorders, cognitive impairment Recent illicit drug use Alcohol dependence Neurological disease and/or history of neurological disease Psychiatric disease and/or history of psychiatric disease Anti-inflammatory treatment Psychotropic treatment Treatments that interfere with heart rate (e.g., beta-blockers, calcium channel blockers, a1 receptor agonists) Persons deprived of liberty, persons hospitalized without consent, persons admitted to a health or social institution for purposes other than research (L-1121-5 to L-1121-8-1) Protected adults, adults unable to express their consent and not subject to a protective measure Participation in other simultaneous trials if this or these protocols concern a pharmacological clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: a group of parabolic flyers with and without prior experience of microgravity
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Microgravity condition<br>a group of parabolic flyers exposed to micro and partial gravity | Other: Cognition and emotional neuropsychologicl evaluations<br>* Cognitive ans sensory performances during repetitive micro and partial gravity exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological data | Freiburg Mindfulness Inventory questionnaire of 14 items (each item has a score from 1 to 4 i.e. minimal value 14 and maximal value 56, with a couple of reversed item to score) | one hour before the flight | 
| Psychological data | Freiburg Mindfulness Inventory questionnaire of 14 items (each item has a score from 1 to 4 i.e. minimal value 14 and maximal value 56, with a couple of reversed item to score) | one hour after the flight | 
| stress | Perceived Stress Scale questionnaire: 10 item-questionnaire to perceive stress (each item from 0 to 4: minimal value 0/no stress and maximal value 40 highest stress level) | one hour before the flight | 
| stress | Perceived Stress Scale questionnaire: 10 item-questionnaire to perceive stress (each item from 0 to 4: minimal value 0/no stress and maximal value 40 highest stress level) | one hour after the flight | 
| Cognition | Cognitive test battery questionnaire, 2D and 3D testing during one session: three scores ponderated (each with 6 plots represented with a spider graph measuring the surface from arbitrary unit) | one hour before the flight | 
| Cognition | Cognitive test battery questionnaire, 2D and 3D testing during one session: three scores ponderated (each with 6 plots represented with a spider graph measuring the surface from arbitrary unit) | one hour after the flight | 
| Olfaction | Olfactive discrimination test | one hour before the flight | 
| Olfaction | Olfactive discrimination test | one hour after the flight | 
| Posture | Ellipse of the center of gravity measurment | one hour before the flight | 
| Posture | Ellipse of the center of gravity measurment | one hour after the flight | 
| Physiological data | Heart Rate variability | Continuous recording all along microgravity exposure up to 1hour after the end of the flight | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adaptation, cognition, extreme environment, confined environment, stress, performances, olfaction, somesthesia, space mission