Healthy ParticipantsREVIAGENCT05996250
Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects
A study testing Immersive virtual reality task in people with Healthy Participants, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Spatial navigation is a high-level cognitive function allowing animals and humans to orient and move in space by constructing a mental representation of the environment. This function has been identified as one of the very first to be affected by Alzheimer's disease, including at the early stages, before the… Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Immersive virtual reality task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2023to 28 May 2024
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant aged 60 to 85
- Participant affiliated or entitled to a social security scheme
- Recruited participants must have been informed and consented in writing
Who cannot join
- Participant with a diagnosis of cognitive impairment
- Severe, progressive or unstable pathology whose nature may interfere with the evaluation variables (epilepsy, psychiatric or psychotic disorders in the acute phase, visual hallucinations, acute infection, lack of sleep)
- Participant equipped with a pacemaker
- Burns or sores on the upper part of the face or on the scalp
- Consumption of toxic substances that can influence cognitive performance
- Deafness or blindness that may compromise participant assessment or completion of tasks and scales
Show all 12Show fewer
- Participant under guardianship or curatorship or legal safeguard
- Participant refusing to use an immersive virtual reality tool
- Criterion for stopping the procedure under study: stopping the virtual reality task due to the participant's simulator sickness.
- Montreal Cognitive Assessment (MOCA) score less than 26
- MacNair Subjective Complaint Scale score greater than 16
- AGGIR score (Autonomy, Gerontology Group Iso Resources) less than 5
Trial locations and contacts
1 site in 1 country.
France1 site
Charpennes Geriatric Hospital, Lyon University Hospital
Villeurbanne, 69100
About this study
Official title: Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects and the Effects of Age, Gender and Level of Education on Performance
Spatial navigation is a high-level cognitive function allowing animals and humans to orient and move in space by constructing a mental representation of the environment. This function has been identified as one of the very first to be affected by Alzheimer's disease, including at the early stages, before the appearance of other mnesic disorders that the latter causes, such as those of episodic memory. However, the neuropsychological tests currently used in the diagnosis of cognitive disorders do not allow effective assessment of spatial memory impairment, in particular because it is impractical to offer spatial orientation tasks in a consulting room. In this context, virtual reality offers very interesting perspectives: it makes it possible to create controlled environments to assess spatial memory, without leaving the place of consultation.
Before being able to test its possible diagnostic efficacy, it is imperative to test the feasibility as well as the reliability of this type of task on an elderly population with no cognitive impairment. The data currently available on immersion tolerance in virtual reality mainly concern young people aged 18 to 35 and little data is available concerning the elderly or very old.
Read more
If this task correctly assesses spatial navigation abilities, this study should find the effects of age and sex usually observed.
The aim of this study is to assess the tolerance of an immersive virtual reality task evaluating the spatial memory of elderly subjects and the effects of age, gender and level of education on performance.
- Conditions
- Healthy Participants
- Being tested
- Immersive virtual reality task
- Keywords
- Virtual reality, ageing, spatial memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive virtual reality taskOther
participants will have to wear a virtual reality headset connected to a remote control and will have to perform submersive virtual reality tasks
| Study group | Role | What they receive |
|---|---|---|
| Immersive virtual reality task | Other | The immersive virtual reality task, specifically designed for this research, is an adaptation to humans of Morris Pool. The virtual environment is composed of a circular arena 22 virtual meters in diameter, delimited by a low wall. It features two visual landmarks and an invisible object to find. The activity includes a control training sequence, an evaluation sequence and a delayed recall performed approximately 20 minutes after the end of the evaluation sequence.
The immersive reality task is performed once by the participants (the study consists on one visit). Receives: Other: Immersive virtual reality task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sickness Simulator Questionnaire (SSQ) score
This is a questionnaire composed of 16 items covering the potential symptoms of intolerance to a virtual reality tool.
Each item is rated 0 (no symptom), 1 (mild symptom), 2 (moderate symptom) or 3 (severe symptom). The total score is obtained by multiplying the sum of the items by 3.74, and therefore varies from 0 to 180.
Measured: The sickness simulator scale is assessed immediately after the immersive virtual reality task.
Secondary outcomes (4)
Time to complete the task in immersive virtual reality according to the age of the participants
Time to complete the task in immersive virtual reality (in seconds) according to the age of participants (in years)
Measured: through study completion, 1 year
Time to complete the task in immersive virtual reality (in seconds) according to the gender of participants (male or female)
Time to complete the task in immersive virtual reality according to the gender of participants
Measured: through study completion, 1 year
Time to complete the task in immersive virtual reality according to the number of years of study
Time to complete the task in immersive virtual reality (in seconds) according to the number of years of study (from entry into primary school)
Measured: through study completion, 1 year
Raw score on the Wechsler Memory Scale-III (MEM III) Spatial Memory subtest
The test is designed for adults and the elderly to assess the performance of auditory memory, visual memory, memory immediate, delayed and visual working memory.The subtest used is the Spatial Memory subtest, it ranges from 0 to 28 (the higher the score, the better the performance).
Measured: through study completion, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start25 Sep 2023
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 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
- NCT05996250
- Sponsor's protocol ID
- 69HCL22_0203
- Acronym
- REVIAGE
- Status last verified
- Jun 2024
- First submitted
- 1 Aug 2023
- Last updated
- 5 Jun 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 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects and the Effects of Age, Gender and Level of Education on Performance
- ClinicalTrials.gov ID
- NCT05996250
- Acronym / sponsor ID
- REVIAGE / 69HCL22_0203
- Conditions
- Healthy Participants
- Keywords
- Virtual reality, ageing, spatial memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 18 Aug 2023 (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.
Spatial navigation is a high-level cognitive function allowing animals and humans to orient and move in space by constructing a mental representation of the environment. This function has been identified as one of the very first to be affected by Alzheimer's disease, including at the early stages, before the appearance of other mnesic disorders that the latter causes, such as those of episodic memory. However, the neuropsychological tests currently used in the diagnosis of cognitive disorders do not allow effective assessment of spatial memory impairment, in particular because it is impractical to offer spatial orientation tasks in a consulting room. In this context, virtual reality offers very interesting perspectives: it makes it possible to create controlled environments to assess spatial memory, without leaving the place of consultation.
Before being able to test its possible diagnostic efficacy, it is imperative to test the feasibility as well as the reliability of this type of task on an elderly population with no cognitive impairment. The data currently available on immersion tolerance in virtual reality mainly concern young people aged 18 to 35 and little data is available concerning the elderly or very old.
If this task correctly assesses spatial navigation abilities, this study should find the effects of age and sex usually observed.
The aim of this study is to assess the tolerance of an immersive virtual reality task evaluating the spatial memory of elderly subjects and the effects of age, gender and level of education on performance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immersive virtual reality task | Other | Other: Immersive virtual reality taskThe immersive virtual reality task, specifically designed for this research, is an adaptation to humans of Morris Pool. The virtual environment is composed of a circular arena 22 virtual meters in diameter, delimited by a low wall. It features two visual landmarks and an invisible object to find. The activity includes a control training sequence, an evaluation sequence and a delayed recall performed approximately 20 minutes after the end of the evaluation sequence. The immersive reality task is performed once by the participants (the study consists on one visit). |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant aged 60 to 85
- Participant affiliated or entitled to a social security scheme
- Recruited participants must have been informed and consented in writing
Key exclusion criteria (12 listed)
- Participant with a diagnosis of cognitive impairment
- Severe, progressive or unstable pathology whose nature may interfere with the evaluation variables (epilepsy, psychiatric or psychotic disorders in the acute phase, visual hallucinations, acute infection, lack of sleep)
- Participant equipped with a pacemaker
- Burns or sores on the upper part of the face or on the scalp
- Consumption of toxic substances that can influence cognitive performance
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 |
|---|---|---|
| Immersive virtual reality taskparticipants will have to wear a virtual reality headset connected to a remote control and will have to perform submersive virtual reality tasks | Other | Immersive virtual reality task |
Primary outcome
Sickness Simulator Questionnaire (SSQ) score
Time frame: The sickness simulator scale is assessed immediately after the immersive virtual reality task.
This is a questionnaire composed of 16 items covering the potential symptoms of intolerance to a virtual reality tool. Each item is rated 0 (no symptom), 1 (mild symptom), 2 (moderate symptom) or 3 (severe symptom). The total score is obtained by multiplying the sum of the items by 3.74, and therefore varies from 0 to 180.
4 secondary outcomes
Time to complete the task in immersive virtual reality according to the age of the participants
Time frame: through study completion, 1 year
Time to complete the task in immersive virtual reality (in seconds) according to the gender of participants (male or female)
Time frame: through study completion, 1 year
Time to complete the task in immersive virtual reality according to the number of years of study
Time frame: through study completion, 1 year
Raw score on the Wechsler Memory Scale-III (MEM III) Spatial Memory subtest
Time frame: through study completion, 1 year
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 5 Jun 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?
A study testing Immersive virtual reality task in people with Healthy Participants, 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 5 Jun 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?
Sickness Simulator Questionnaire (SSQ) score (time frame: The sickness simulator scale is assessed immediately after the immersive virtual reality task.). 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 5 Jun 2024.