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Body-environment Relationship Related Modified Gravity (ENACT)

C

Caen University Hospital

Status

Completed

Conditions

Body Schema

Treatments

Other: Cognition and emotional neuropsychologicl evaluations

Study type

Interventional

Funder types

Other

Identifiers

NCT05531162
2022-A01317-36

Details and patient eligibility

About

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)

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Microgravity condition
Other group
Description:
a group of parabolic flyers exposed to micro and partial gravity
Treatment:
Other: Cognition and emotional neuropsychologicl evaluations

Trial contacts and locations

1

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Central trial contact

Stephane BESNARD

Data sourced from clinicaltrials.gov

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