Body-environment Relationship Related Modified Gravity

NCT05531162 | Completed

• 1 other identifier: 2022-A01317-36
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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)

Conditions

Body Schema

Keywords

adaptation; cognition; extreme environment; confined environment; stress; performances; olfaction; somesthesia; space mission

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

Microgravity condition

OTHER

a group of parabolic flyers exposed to micro and partial gravity

Other: Cognition and emotional neuropsychologicl evaluations

Interventions

Cognition and emotional neuropsychologicl evaluations OTHER

Cognitive ans sensory performances during repetitive micro and partial gravity exposure

Microgravity condition

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead
• Institut de Recherche Biomedicale des Armees: collaborator

Study Sites (1)

Caen University Hospital

Caen, 14033, France

Location

MeSH Terms

Conditions

Anosmia

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a group of parabolic flyers with and without prior experience of microgravity

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 7, 2022
• Study Start: October 23, 2022
• Primary Completion: April 26, 2023
• Study Completion: December 23, 2023
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)