Clinical trial NCT05628220: Motion Sickness Desensitization Using VR
Official title: Evaluation and Countermeasures of Motion Sickness by Virtual Reality Desensitization Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Motion Sickness
Keywords: vestibular system
posture
anxiety
nausea
motion sickness
visually induced motion sickness
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: one cohort of patients suffering from motion sickness
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: motion sickness severity
timeFrame: day 0 (day before the first session of rehabilitation)
measure: motion sickness severity
timeFrame: day 30 (day after the end of rehabilitation)
Secondary outcomes:
measure: Emotion
timeFrame: day 0 (day before the first session of rehabilitation)
measure: Emotion
timeFrame: day 30 (day after the end of rehabilitation)
measure: Posture
timeFrame: day 0 (day before the first session of rehabilitation)
measure: Posture
timeFrame: day 30 (day after the end of rehabilitation)
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
city: Vitrolles
country: France
facility: Frédéric Xavier
Study officials:
affiliation: University Hospital, Caen
name: stephane BESNARD, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References: