VR-MARS Virtual Reality, Medical Assistance and Rescue for Space (VR-MARS)

November 17, 2023 updated by: Dr Seamus Thierry, Groupe Hospitalier de Bretagne Sud
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lorient, France, 56100
        • Groupe Hospitalier de Bretagne Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Augmented Reality Headset Usability
In this arm, participants tested the functionality and usability of the headset (a Microsoft Hololens 2 or a Varjor XR3)
Device: Augmented Reality Headset / Hololens 2 or Varjo XR3
Augmented Reality Headset

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day
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.
1 day
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)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier de Bretagne Sud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ID RCB 2019- A03007- 50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Access Criteria

on request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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