Clinical trial NCT05531162: Body-environment Relationship Related Modified Gravity
Official title: Repetitive Gravitationnal Changes on the Body-environment Relationship
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Schema
Keywords: adaptation
cognition
extreme environment
confined environment
stress
performances
olfaction
somesthesia
space mission
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Institut de Recherche Biomedicale des Armees
First posted: 2022-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a group of parabolic flyers with and without prior experience of microgravity
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Psychological data
timeFrame: one hour before the flight
measure: Psychological data
timeFrame: one hour after the flight
measure: stress
timeFrame: one hour before the flight
measure: stress
timeFrame: one hour after the flight
measure: Cognition
timeFrame: one hour before the flight
measure: Cognition
timeFrame: one hour after the flight
measure: Olfaction
timeFrame: one hour before the flight
measure: Olfaction
timeFrame: one hour after the flight
measure: Posture
timeFrame: one hour before the flight
measure: Posture
timeFrame: one hour after the flight
measure: Physiological data
timeFrame: Continuous recording all along microgravity exposure up to 1hour after the end of the flight
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References: