Motion Sickness Desensitization Using VR (SENSORIEL1)

Evaluation and Countermeasures of Motion Sickness by Virtual Reality Desensitization Protocol

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.

Study Overview

• Status: Recruiting
• Conditions: Motion Sickness
• Intervention / Treatment: Other: physiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • Recruiting
    • CAEN University Hospital
  • Vitrolles, France, 13127
    • Recruiting
    • Frédéric Xavier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort of motion sickness; one group of patient	Other: physiotherapy; rehabilitation through using session of virtual reality desensitization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
motion sickness severity	simulator sickness questionnaire (0-64)	day 0 (day before the first session of rehabilitation)
motion sickness severity	simulator sickness questionnaire (0-64)	day 30 (day after the end of rehabilitation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion	The State-Trait Anxiety Questionnaire (0-80)	day 0 (day before the first session of rehabilitation)
Emotion	The State-Trait Anxiety Questionnaire (0-80)	day 30 (day after the end of rehabilitation)
Posture	postural measurement (gravity center ellipse)	day 0 (day before the first session of rehabilitation)
Posture	postural measurement (gravity center ellipse)	day 30 (day after the end of rehabilitation)

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: stephane BESNARD, Md,PhD, University Hospital, Caen

Publications and helpful links

Helpful Links

• topical team motion sickness

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: nausea; anxiety; posture; motion sickness; vestibular system; visually induced motion sickness
• Additional Relevant MeSH Terms: Motion Sickness
• Other Study ID Numbers: 17-083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No