Body-environment Relationship Related Modified Gravity

Not Applicable

Not yet recruiting

• Conditions: Body Schema
• Interventions: Other: Cognition and emotional neuropsychologicl evaluations

• Registration Number: NCT05531162
• Lead Sponsor: University Hospital, Caen

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-08-30
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-05
• Last Update Submitted: 2022-09-05
• Study First Posted: 2022-09-07
• Last Update Posted: 2022-09-07
• Study Start: 2022-10-23
• Primary Completion: 2023-12-23
• Study Completion: 2023-12-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microgravity condition	Cognition and emotional neuropsychologicl evaluations	a group of parabolic flyers exposed to micro and partial gravity

Primary Outcome Measures

Name	Time	Method
Posture	one hour after the flight	Ellipse of the center of gravity measurment
Psychological data	one hour after the flight	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)
stress	one hour after the flight	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)
Olfaction	one hour after the flight	Olfactive discrimination test
Physiological data	Continuous recording all along microgravity exposure up to 1hour after the end of the flight	Heart Rate variability
Cognition	one hour after the flight	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)

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France