Body-environment Relationship Related Modified Gravity (ENACT)

Repetitive Gravitationnal Changes on the Body-environment Relationship

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)

Study Overview

• Status: Completed
• Conditions: Body Schema
• Intervention / Treatment: Other: Cognition and emotional neuropsychologicl evaluations

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • Caen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Institut de Recherche Biomedicale des Armees

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2022
• Primary Completion (Actual): April 26, 2023
• Study Completion (Actual): December 23, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: cognition; stress; adaptation; olfaction; somesthesia; extreme environment; confined environment; performances; space mission
• Other Study ID Numbers: 2022-A01317-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No