MedDataX Logo

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

NCT ID: NCT06144658

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Instructional Virtual Realities Weightlessness Simulation Space Simulation Patient Simulation High Fidelity Simulation Training

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Augmented Reality Headset Usability

In this arm, participants tested the functionality and usability of the headset (a Microsoft Hololens 2 or a Varjor XR3)

Group Type EXPERIMENTAL

Augmented Reality Headset / Hololens 2 or Varjo XR3

Intervention Type DEVICE

Augmented Reality Headset

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Augmented Reality Headset / Hololens 2 or Varjo XR3

Augmented Reality Headset

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Groupe Hospitalier de Bretagne Sud

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Seamus Thierry

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Groupe Hospitalier de Bretagne Sud

Lorient, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ID RCB 2019- A03007- 50

Identifier Type: -

Identifier Source: org_study_id