Healthy PersonVIVRANCT06213792
Visuo-Vestibular Adaptation in Virtual Reality
An observational study of Healthy Person, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The vestibulo-ocular reflex (VOR) stabilizes the gaze during rapid head movements by inducing an eye rotation of equivalent amplitude but in the opposite direction to the head rotation. Normally, the ratio of eye rotation amplitude to head rotation, or VOR gain, is 1. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Healthy Person
- What is being tested?
- Adaptation of the VOR
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2024to 2 May 2024
- Phase
- Observational
- 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 60 years
- All sexes
- Adult
Study population: healthy subjects
Who may be able to join
- Age from 18 to 60
- Understanding of the experimental instructions
- Informed Consent
Who cannot join
- Underlying ENT or neurological disorders
- Corrected Visual Acuity lower than 5/10
- Other conditions leading to oscillopsia or ataxia
- Oculomotor palsy, ocular instability in primary position
- Treatment that may affect ocular motility (psychotropes)
- Cervical rachis pathology with instability
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- Cochlear Implants
- Non-stabilized medical disease
- Subject suffering from debilitating motion sickness or Virtual Reality sickness
- Pregnant women
- Patients under tutelage
- Patient without social security
Trial locations and contacts
1 site in 1 country.
About this study
The vestibulo-ocular reflex (VOR) stabilizes the gaze during rapid head movements by inducing an eye rotation of equivalent amplitude but in the opposite direction to the head rotation. Normally, the ratio of eye rotation amplitude to head rotation, or VOR gain, is 1. Under some conditions such as growth or the use of corrective glasses, this gain is adapted to the new visuo-vestibular conditions. This well-known sensorimotor adaptation phenomenon can be achieved through the experimental creation of a conflict between vestibular and visual information.
Incremental velocity error (IVE) allows for a rapid adaption of the VOR at high speed by synchronously projecting a laser target that moves to create a progressively increasing visuo-vestibular conflict. However, this method does not correspond to the ecological conditions of VOR use, as the training is conducted in darkness and the visuo-vestibular conflict does not involve the entire visual scene.
Recreating this type of adaptation in a virtual reality environment could allow for adaptation with a visual stimulus involving the entire visual scene, thus more closely resembling the physiological conditions of VOR use. We hypothesize that a visual simulation of the entire scene would be more effective than an isolated target in VOR adaptation during high velocity head rotation.
- Conditions
- Healthy Person
- Being tested
- Adaptation of the VOR
- Keywords
- Vestibulo-Ocular Reflex, Adaptation, Head Impulse Test, Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptation of the VOROther
Subjects will undergo adaptation of their VOR in virtual reality in two different conditions. The side on which the adaptation will take place and the type of condition with which the patients will start will be randomized. Subject will undergo passive rapid head movements done by an experienced examinator whilst fixing a target in front of them. The movement of the target relative to the movement of the head will increase every 90 seconds by 10% until the movement of the visual scene is twice that of the head movement. In one condition the visual scene will be only a target in a grey void. In the other condition the visual scene will be more complex and represent a target in the room in which the subject is seated. Subjects will undergo both conditions at least 7 days apart.
What is being measured
The primary outcome is the main question the study is designed to answer.
VOR gain
VOR gain corresponds to the amplitude of the eye rotation devided by the amplitude of the head rotation for a given head impulse.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start4 Apr 2024
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PersonStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213792
- Sponsor's protocol ID
- 69HCL23_1326
- Acronym
- VIVRA
- Status last verified
- Apr 2024
- First submitted
- 10 Jan 2024
- Last updated
- 16 May 2024
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visuo-Vestibular Adaptation in Virtual Reality
- ClinicalTrials.gov ID
- NCT06213792
- Acronym / sponsor ID
- VIVRA / 69HCL23_1326
- Conditions
- Healthy Person
- Keywords
- Vestibulo-Ocular Reflex, Adaptation, Head Impulse Test, Virtual Reality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 19 Jan 2024 (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.
The vestibulo-ocular reflex (VOR) stabilizes the gaze during rapid head movements by inducing an eye rotation of equivalent amplitude but in the opposite direction to the head rotation. Normally, the ratio of eye rotation amplitude to head rotation, or VOR gain, is 1. Under some conditions such as growth or the use of corrective glasses, this gain is adapted to the new visuo-vestibular conditions. This well-known sensorimotor adaptation phenomenon can be achieved through the experimental creation of a conflict between vestibular and visual information.
Incremental velocity error (IVE) allows for a rapid adaption of the VOR at high speed by synchronously projecting a laser target that moves to create a progressively increasing visuo-vestibular conflict. However, this method does not correspond to the ecological conditions of VOR use, as the training is conducted in darkness and the visuo-vestibular conflict does not involve the entire visual scene.
Recreating this type of adaptation in a virtual reality environment could allow for adaptation with a visual stimulus involving the entire visual scene, thus more closely resembling the physiological conditions of VOR use. We hypothesize that a visual simulation of the entire scene would be more effective than an isolated target in VOR adaptation during high velocity head rotation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- healthy subjects
Key inclusion criteria (3 listed)
- Age from 18 to 60
- Understanding of the experimental instructions
- Informed Consent
Key exclusion criteria (12 listed)
- Underlying ENT or neurological disorders
- Corrected Visual Acuity lower than 5/10
- Other conditions leading to oscillopsia or ataxia
- Oculomotor palsy, ocular instability in primary position
- Treatment that may affect ocular motility (psychotropes)
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 |
|---|---|---|
| Adaptation of the VORSubjects will undergo adaptation of their VOR in virtual reality in two different conditions. The side on which the adaptation will take place and the type of condition with which the patients will start will be randomized. Subject will undergo passive rapid head movements done by an experienced examinator whilst fixing a target in front of them. The movement of the target relative to the movement of the head will increase every 90 seconds by 10% until the movement of the visual scene is twice that of the head movement. In one condition the visual scene will be only a target in a grey void. In the other condition the visual scene will be more complex and represent a target in the room in which the subject is seated. Subjects will undergo both conditions at least 7 days apart. | Other | – |
Primary outcome
VOR gain
Time frame: 7 days
VOR gain corresponds to the amplitude of the eye rotation devided by the amplitude of the head rotation for a given head impulse.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Person, run by Hospices Civils de Lyon at 1 site 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VOR gain (time frame: 7 days). 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 16 May 2024.