Instructional Virtual RealitiesVR-MARSNCT06144658
VR-MARS Virtual Reality, Medical Assistance and Rescue for Space
A study testing Augmented Reality Headset / Hololens 2 or Varjo XR3 in people with Instructional Virtual Realities and Weightlessness Simulation, run by Groupe Hospitalier de Bretagne Sud at 1 site in France.
Trial summary
VRMARS is a medical simulation study in microgravity. Healthy volunteers (n=18) test in microgravity the functionnality of an augmented reality headset in which a medical assistance is displayed. Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Instructional Virtual Realities, Weightlessness Simulation, Space Simulation
- What is being tested?
- Augmented Reality Headset / Hololens 2 or Varjo XR3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 30 Mar 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 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female volunteers.
- Aged between 18 and 66.
- Not currently pregnant.
- Affiliated to a social security system or, for non-Europeans, holders of a European Health Insurance Card (EHIC).
- Have signed written consent for the study.
- Have passed a standard JAR FCL3 Class 2 (Private Pilot Aptitude) medical examination less than 1 year old.
Who cannot join
- On the day of the flight, before the volunteer boards the plane:
- Flu, digestive symptoms (nausea, vomiting), fever.
- Pregnancy: a urine pregnancy test will be performed on the morning of the flight before boarding.
- Altered mental state (flight anxiety, phobia).
- Failure to attend the safety briefing.
- During the flight :
- Non-compliance with basic safety instructions.
- Flight-related side effects: fatigue, motion sickness.
Trial locations and contacts
1 site in 1 country.
About this study
VRMARS is a medical simulation study in microgravity. Healthy volunteers (n=18) test in microgravity the functionnality of an augmented reality headset in which a medical assistance is displayed.
- Conditions
- Instructional Virtual Realities, Weightlessness Simulation, Space Simulation, Patient Simulation, High Fidelity Simulation Training
- Being tested
- Augmented Reality Headset / Hololens 2 or Varjo XR3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality Headset / Hololens 2 or Varjo XR3Device
Augmented Reality Headset
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality Headset Usability | Experimental | In this arm, participants tested the functionality and usability of the headset (a Microsoft Hololens 2 or a Varjor XR3) Receives: Device: Augmented Reality Headset / Hololens 2 or Varjo XR3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical validation of the headset in microgravity
The participant had to report to the invistigators whether the headset functioned under microgravity. Images superimposed on the real environment had to be correctly placed and stable in zero-G
Measured: 1 day
Usability test HARUS / Form
The HARUS (Handheld Augmented Reality Usability Scale) is a questionnaire measuring manipulability -- the ease of handling the HAR system, and comprehensibility -- the ease of understanding the information presented by augmented reality.
Measured: 1 day
NASA-TLX cognitive test
The NASA TLX is a subjective, multidimensional assessment tool that rates perceived workload in order to assess a task, system, or team's effectiveness or other aspects of performance (task loading)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Oct 2020
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Instructional Virtual RealitiesStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de Bretagne Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Seamus Thierry, Groupe Hospitalier de Bretagne Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144658
- Sponsor's protocol ID
- ID RCB 2019- A03007- 50
- Acronym
- VR-MARS
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR-MARS Virtual Reality, Medical Assistance and Rescue for Space
- ClinicalTrials.gov ID
- NCT06144658
- Acronym / sponsor ID
- VR-MARS / ID RCB 2019- A03007- 50
- Conditions
- Instructional Virtual Realities, Weightlessness Simulation, Space Simulation, Patient Simulation, High Fidelity Simulation Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Groupe Hospitalier de Bretagne SudUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 22 Nov 2023 (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.
VRMARS is a medical simulation study in microgravity. Healthy volunteers (n=18) test in microgravity the functionnality of an augmented reality headset in which a medical assistance is displayed.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality Headset Usability | Experimental | Device: Augmented Reality Headset / Hololens 2 or Varjo XR3In this arm, participants tested the functionality and usability of the headset (a Microsoft Hololens 2 or a Varjor XR3) |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male or female volunteers.
- Aged between 18 and 66.
- Not currently pregnant.
- Affiliated to a social security system or, for non-Europeans, holders of a European Health Insurance Card (EHIC).
- Have signed written consent for the study.
Key exclusion criteria (8 listed)
- Flu, digestive symptoms (nausea, vomiting), fever.
- Pregnancy: a urine pregnancy test will be performed on the morning of the flight before boarding.
- Altered mental state (flight anxiety, phobia).
- Failure to attend the safety briefing.
- Non-compliance with basic safety instructions.
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 |
|---|---|---|
| Augmented Reality Headset / Hololens 2 or Varjo XR3Augmented Reality Headset | Device | Augmented Reality Headset Usability |
Primary outcome
Technical validation of the headset in microgravity
Time frame: 1 day
The participant had to report to the invistigators whether the headset functioned under microgravity. Images superimposed on the real environment had to be correctly placed and stable in zero-G
Usability test HARUS / Form
Time frame: 1 day
The HARUS (Handheld Augmented Reality Usability Scale) is a questionnaire measuring manipulability -- the ease of handling the HAR system, and comprehensibility -- the ease of understanding the information presented by augmented reality.
NASA-TLX cognitive test
Time frame: 1 day
The NASA TLX is a subjective, multidimensional assessment tool that rates perceived workload in order to assess a task, system, or team's effectiveness or other aspects of performance (task loading)
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 22 Nov 2023.
- Individual participant dataSharing planned: Yes
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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 Augmented Reality Headset / Hololens 2 or Varjo XR3 in people with Instructional Virtual Realities and Weightlessness Simulation, run by Groupe Hospitalier de Bretagne Sud 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 8 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 22 Nov 2023. 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?
Technical validation of the headset in microgravity (time frame: 1 day). The study lists 3 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 22 Nov 2023.