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Motion Sickness Desensitization Using VR (SENSORIEL1)

Primary Purpose

Motion Sickness

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
physiotherapy
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motion Sickness focused on measuring vestibular system, posture, anxiety, nausea, motion sickness, visually induced motion sickness

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Suffering from motion sickness inducing a functional disability requiring a change in the mode of travel, or suffering from motion sickness disabling to exercise a leisure or professional activity involving a mode of locomotion. Exclusion Criteria: Pregnant woman History of severe ENT or ophthalmologic pathologies. Chronic treatment with an anticholinergic or anti-histamine medication. Participating in another biomedical research protocol during the same period Person under guardianship or curatorship

Sites / Locations

  • Caen University HospitalRecruiting
  • Frédéric XavierRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cohort of motion sickness

Arm Description

one group of patient

Outcomes

Primary Outcome Measures

motion sickness severity
simulator sickness questionnaire (0-64)
motion sickness severity
simulator sickness questionnaire (0-64)

Secondary Outcome Measures

Emotion
The State-Trait Anxiety Questionnaire (0-80)
Emotion
The State-Trait Anxiety Questionnaire (0-80)
Posture
postural measurement (gravity center ellipse)
Posture
postural measurement (gravity center ellipse)

Full Information

First Posted
September 8, 2022
Last Updated
November 24, 2022
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT05628220
Brief Title
Motion Sickness Desensitization Using VR
Acronym
SENSORIEL1
Official Title
Evaluation and Countermeasures of Motion Sickness by Virtual Reality Desensitization Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of a virtual reality desensitization protocol on subjects with severe motion sickness and study of the role of the emotional component on the effectiveness of the therapy.
Detailed Description
Motion sickness is a well-known syndrome, particularly at risk in children, with a maximum around the age of 12. All people are sensitive to motion sickness in childhood, probably related to the maturation of certain cognitive functions of a spatial nature, namely the perception of oneself and one's movements in one's environment. These symptoms regress with age for a part of the population but a large number of people will remain sensitive to certain conditions of displacement and generate symptoms that can be extremely disabling and handicapping in everyday life, particularly for professional activities. For example, some people can no longer use their car, some can no longer take the boat for professional activities in restrictive and/or extreme environments (sailors, scientists, workers, etc.). Behavioral, respiratory or medicinal therapies remain partially effective due to the lack of sufficient knowledge on the physiopathology of this syndrome classified in the field of sensory disorders. Very recently, techniques of sensory desensitization by visual stimulation have appeared, either optokinetic or in virtual reality mimicking the environment that causes this syndrome. This therapeutic approach seems to give empirically good results but only one study has shown it with optokinetic stimulation but it is to be evaluated for virtual reality. The main objective of the study is therefore to evaluate the effectiveness of a sensory conflict protocol generated in virtual reality to reduce the severity of motion sickness. Each subject being his own control. An observational study was then designed to quantify the effectiveness of this technique carried out in a current way by the physiotherapists in the form of questionnaires supplemented by a posturographic evaluation of the sensory profile of the subjects. If the effectiveness is proven, this desensitization protocol could be optimized and more widely distributed. Furthermore, the analysis of the visuo-dependence variable (from the sensory profile) will indicate whether the use of a visual stimulus by virtual reality alone is sufficient or should be combined or compared with desensitization of other sensory modalities. The use of galvanic vestibular stimulation for the rehabilitation of vestibular pathologies or training programs based on the resolution of sensory conflicts could be envisaged in the future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motion Sickness
Keywords
vestibular system, posture, anxiety, nausea, motion sickness, visually induced motion sickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
one cohort of patients suffering from motion sickness
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort of motion sickness
Arm Type
Other
Arm Description
one group of patient
Intervention Type
Other
Intervention Name(s)
physiotherapy
Intervention Description
rehabilitation through using session of virtual reality desensitization
Primary Outcome Measure Information:
Title
motion sickness severity
Description
simulator sickness questionnaire (0-64)
Time Frame
day 0 (day before the first session of rehabilitation)
Title
motion sickness severity
Description
simulator sickness questionnaire (0-64)
Time Frame
day 30 (day after the end of rehabilitation)
Secondary Outcome Measure Information:
Title
Emotion
Description
The State-Trait Anxiety Questionnaire (0-80)
Time Frame
day 0 (day before the first session of rehabilitation)
Title
Emotion
Description
The State-Trait Anxiety Questionnaire (0-80)
Time Frame
day 30 (day after the end of rehabilitation)
Title
Posture
Description
postural measurement (gravity center ellipse)
Time Frame
day 0 (day before the first session of rehabilitation)
Title
Posture
Description
postural measurement (gravity center ellipse)
Time Frame
day 30 (day after the end of rehabilitation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suffering from motion sickness inducing a functional disability requiring a change in the mode of travel, or suffering from motion sickness disabling to exercise a leisure or professional activity involving a mode of locomotion. Exclusion Criteria: Pregnant woman History of severe ENT or ophthalmologic pathologies. Chronic treatment with an anticholinergic or anti-histamine medication. Participating in another biomedical research protocol during the same period Person under guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
stephane besnard, MD, PhD
Phone
+33677978649
Email
stephane.besnard@unicaen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
stephane BESNARD, Md,PhD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane BESNARD, MD, PhD
Phone
+33231065332
Email
stephane.besnard@unicaen.fr
First Name & Middle Initial & Last Name & Degree
Stéphane BESNARD, MD, PhD
First Name & Middle Initial & Last Name & Degree
Martin HITIER, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sylvain MOREAU, MD, PhD
First Name & Middle Initial & Last Name & Degree
Laetitia PLISSON, MD
Facility Name
Frédéric Xavier
City
Vitrolles
ZIP/Postal Code
13127
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric XAVIER, PhD
Phone
+33231065332
Email
frederic.xavier@etu.univ-amu.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://gdrvertige.com/
Description
topical team motion sickness

Learn more about this trial

Motion Sickness Desensitization Using VR

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