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Completed

NCT Number: NCT05531162

Body-environment Relationship Related Modified Gravity

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)

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Key information

Conditions

Body Schema Anosmia Nervous System Diseases Neurologic Manifestations Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital

Caen, 14033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognition and emotional neuropsychologicl evaluations

Other

Cognitive ans sensory performances during repetitive micro and partial gravity exposure

Primary outcomes

  1. Psychological data

    Time frame: one hour before 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)

  2. Psychological data

    Time frame: 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)

  3. stress

    Time frame: one hour before 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)

  4. stress

    Time frame: 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)

  5. Cognition

    Time frame: one hour before 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)

  6. Cognition

    Time frame: 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)

  7. Olfaction

    Time frame: one hour before the flight

    Olfactive discrimination test

  8. Olfaction

    Time frame: one hour after the flight

    Olfactive discrimination test

  9. Posture

    Time frame: one hour before the flight

    Ellipse of the center of gravity measurment

  10. Posture

    Time frame: one hour after the flight

    Ellipse of the center of gravity measurment

  11. Physiological data

    Time frame: Continuous recording all along microgravity exposure up to 1hour after the end of the flight

    Heart Rate variability

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • Institut de Recherche Biomedicale des Armees

Registry information

Official study title

Repetitive Gravitationnal Changes on the Body-environment Relationship

Acronym: ENACT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2022
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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