Body-environment Relationship Related Modified Gravity

NCT ID: NCT05531162

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-23
• Study Completion Date: 2023-12-23

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.

Conditions

Body Schema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Microgravity condition

a group of parabolic flyers exposed to micro and partial gravity

Group Type: OTHER

Cognition and emotional neuropsychologicl evaluations

Intervention Type: OTHER

Cognitive ans sensory performances during repetitive micro and partial gravity exposure

Interventions

Cognition and emotional neuropsychologicl evaluations

Cognitive ans sensory performances during repetitive micro and partial gravity exposure

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Recherche Biomedicale des Armees

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Caen University Hospital

Caen, , France

Countries

France

Other Identifiers

2022-A01317-36

Identifier Type: -

Identifier Source: org_study_id