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

Sponsor
Groupe Hospitalier de Bretagne Sud (Other)
Overall Status
Completed
CT.gov ID
NCT06144658
Collaborator
(none)
18
Enrollment
1
Location
1
Arm
29.9
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Augmented Reality Headset / Hololens 2 or Varjo XR3
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
VR-MARS Virtual Reality, Medical Assistance and Rescue for Space
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Mar 30, 2023
Actual Study Completion Date :
Mar 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Technical validation of the headset in microgravity [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

  2. Usability test HARUS / Form [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.

  3. NASA-TLX cognitive test [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 66 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Groupe Hospitalier de Bretagne Sud Lorient France 56100

Sponsors and Collaborators

  • Groupe Hospitalier de Bretagne Sud

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Seamus Thierry, Medical Doctor, Groupe Hospitalier de Bretagne Sud
ClinicalTrials.gov Identifier:
NCT06144658
Other Study ID Numbers:
  • ID RCB 2019- A03007- 50
First Posted:
Nov 22, 2023
Last Update Posted:
Nov 22, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 22, 2023