Body SchemaENACTNCT05531162
Body-environment Relationship Related Modified Gravity
A study testing Cognition and emotional neuropsychologicl evaluations in people with Body Schema, run by University Hospital, Caen at 1 site in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Body Schema
- What is being tested?
- Cognition and emotional neuropsychologicl evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2022to 23 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Repetitive Gravitationnal Changes on the Body-environment Relationship
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)
Read the 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
- Being tested
- Cognition and emotional neuropsychologicl evaluations
- Keywords
- adaptation, cognition, extreme environment, confined environment, stress, performances, olfaction, somesthesia, space mission
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognition and emotional neuropsychologicl evaluationsOther
Cognitive ans sensory performances during repetitive micro and partial gravity exposure
| Study group | Role | What they receive |
|---|---|---|
| Microgravity condition | Other | a group of parabolic flyers exposed to micro and partial gravity Receives: Other: Cognition and emotional neuropsychologicl evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: one hour after the flight
Olfaction
Olfactive discrimination test
Measured: one hour before the flight
Olfaction
Olfactive discrimination test
Measured: one hour after the flight
Posture
Ellipse of the center of gravity measurment
Measured: one hour before the flight
Posture
Ellipse of the center of gravity measurment
Measured: one hour after the flight
Physiological data
Heart Rate variability
Measured: Continuous recording all along microgravity exposure up to 1hour after the end of the flight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start23 Oct 2022
- Primary completion26 Apr 2023
- Study completion23 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body SchemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a group of parabolic flyers with and without prior experience of microgravity
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche Biomedicale des Armees
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531162
- Sponsor's protocol ID
- 2022-A01317-36
- Acronym
- ENACT
- Status last verified
- Jul 2025
- First submitted
- 30 Aug 2022
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Gravitationnal Changes on the Body-environment Relationship
- ClinicalTrials.gov ID
- NCT05531162
- Acronym / sponsor ID
- ENACT / 2022-A01317-36
- Conditions
- Body Schema
- Keywords
- adaptation, cognition, extreme environment, confined environment, stress, performances, olfaction, somesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut de Recherche Biomedicale des Armees
- Study start
- 23 Oct 2022 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 23 Dec 2023 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a group of parabolic flyers with and without prior experience of microgravity
| Arm | Type | Receives |
|---|---|---|
| Microgravity condition | Other | Other: Cognition and emotional neuropsychologicl evaluationsa group of parabolic flyers exposed to micro and partial gravity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognition and emotional neuropsychologicl evaluationsCognitive ans sensory performances during repetitive micro and partial gravity exposure | Other | Microgravity condition |
Primary outcome
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)
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)
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)
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)
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)
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)
Olfaction
Time frame: one hour before the flight
Olfactive discrimination test
Olfaction
Time frame: one hour after the flight
Olfactive discrimination test
Posture
Time frame: one hour before the flight
Ellipse of the center of gravity measurment
Posture
Time frame: one hour after the flight
Ellipse of the center of gravity measurment
Physiological data
Time frame: Continuous recording all along microgravity exposure up to 1hour after the end of the flight
Heart Rate variability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognition and emotional neuropsychologicl evaluations in people with Body Schema, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological data (time frame: one hour before the flight). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.