Motion SicknessSENSORIEL1NCT05628220
Motion Sickness Desensitization Using VR
A study testing physiotherapy in people with Motion Sickness, run by University Hospital, Caen at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Motion Sickness
- What is being tested?
- physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Jan 2018to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Caen University Hospital
Caen, 14033
Stéphane BESNARD, MD, PhD, +33231065332, stephane.besnard@unicaen.fr
Stéphane BESNARD, MD, PhD
- Recruiting
Frédéric Xavier
Vitrolles, 13127
Frédéric XAVIER, PhD, +33231065332, frederic.xavier@etu.univ-amu.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Motion Sickness
- Being tested
- physiotherapy
- Keywords
- vestibular system, posture, anxiety, nausea, motion sickness, visually induced motion sickness
- Medical subject headings
- Motion Sickness, Anxiety Disorders, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyOther
rehabilitation through using session of virtual reality desensitization
| Study group | Role | What they receive |
|---|---|---|
| Cohort of motion sickness | Other | one group of patient Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
motion sickness severity
simulator sickness questionnaire (0-64)
Measured: day 0 (day before the first session of rehabilitation)
motion sickness severity
simulator sickness questionnaire (0-64)
Measured: day 30 (day after the end of rehabilitation)
Secondary outcomes (4)
Emotion
The State-Trait Anxiety Questionnaire (0-80)
Measured: day 0 (day before the first session of rehabilitation)
Emotion
The State-Trait Anxiety Questionnaire (0-80)
Measured: day 30 (day after the end of rehabilitation)
Posture
postural measurement (gravity center ellipse)
Measured: day 0 (day before the first session of rehabilitation)
Posture
postural measurement (gravity center ellipse)
Measured: day 30 (day after the end of rehabilitation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start10 Jan 2018
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motion SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- one cohort of patients suffering from motion sickness
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- stephane BESNARD, Md,PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628220
- Sponsor's protocol ID
- 17-083
- Acronym
- SENSORIEL1
- Status last verified
- Aug 2022
- First submitted
- 8 Sep 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Countermeasures of Motion Sickness by Virtual Reality Desensitization Protocol
- ClinicalTrials.gov ID
- NCT05628220
- Acronym / sponsor ID
- SENSORIEL1 / 17-083
- Conditions
- Motion Sickness
- Keywords
- vestibular system, posture, anxiety, nausea, motion sickness, visually induced motion sickness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- one cohort of patients suffering from motion sickness
| Arm | Type | Receives |
|---|---|---|
| Cohort of motion sickness | Other | Other: physiotherapyone group of patient |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiotherapyrehabilitation through using session of virtual reality desensitization | Other | Cohort of motion sickness |
Primary outcome
motion sickness severity
Time frame: day 0 (day before the first session of rehabilitation)
simulator sickness questionnaire (0-64)
motion sickness severity
Time frame: day 30 (day after the end of rehabilitation)
simulator sickness questionnaire (0-64)
4 secondary outcomes
Emotion
Time frame: day 0 (day before the first session of rehabilitation)
Emotion
Time frame: day 30 (day after the end of rehabilitation)
Posture
Time frame: day 0 (day before the first session of rehabilitation)
Posture
Time frame: day 30 (day after the end of rehabilitation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- topical team motion sicknessLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
stephane BESNARD, Md,PhD principal investigator
University Hospital, Caen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy in people with Motion Sickness, run by University Hospital, Caen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact stephane besnard, MD, PhD (+33677978649, stephane.besnard@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motion sickness severity (time frame: day 0 (day before the first session of rehabilitation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.