DementiaNCT07064382
VR-based Multi-dimensional Intervention on Cognitive Function, With AI-agents
A study testing VR-based multi-dimensional intervention in people with Dementia and Sleepiness, run by Hong Kong University of Science and Technology.
Trial summary
Virtual Reality-based multi-dimensional intervention for cognition and well-being will be provided to older adults, with AI-agents. The digital health intervention include physical activity, gamification, cognitive trainings. Read more about this study
- Who is it for?
- Ages 60 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Sleepiness, Mental Health
- What is being tested?
- VR-based multi-dimensional intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 15 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- older adults
Who cannot join
- cannot attend physical activity like pedalling rehabilitation bike
- other health issues (assessed by health professionals)
About this study
Official title: VR-based Multi-dimensional Intervention on Cognitive Function and Well-beings
Virtual Reality-based multi-dimensional intervention for cognition and well-being will be provided to older adults, with AI-agents. The digital health intervention include physical activity, gamification, cognitive trainings. Cognition, like memory, spatial function, sleepiness and mental health will be studied as outcomes.
Read the detailed description
In order to study the cognitive function and well-beings, qualitative methods (like questionnaires, interviews, focus groups) and quantitative methods (like ppg, ecg, eyetracker, eeg) will be used to collect data for analysis.
- Conditions
- Dementia, Sleepiness, Mental Health, Alzheimer Disease
- Being tested
- VR-based multi-dimensional intervention
- Medical subject headings
- Dementia, Sleepiness, Psychological Well-Being, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based multi-dimensional interventionDevice
VR-based multi-dimensional intervention, including LLMs, AI-agents
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | usual care |
| VR-based intervention | Experimental | Provide VR-based multi-dimensional intervention Receives: Device: VR-based multi-dimensional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial cognition
mental rotation task,higher score means stronger spatial ability
Measured: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
Spatial cognition
money road map test, higher score means stronger spatial ability
Measured: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
Spatial cognition
building memory test, higher score means stronger spatial ability
Measured: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
Spatial cognition
corsi, , higher score means stronger spatial ability
Measured: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
Spatial cognition
digit span, higher score means stronger spatial ability
Measured: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
Secondary outcomes (3)
mental health
UCLA loneliness, higher score means more loneliness
Measured: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
mental health
Positive and Negative Affect Schedule , 2 subscare, one is for positive, higher score means more positive affects, one is for negative, higher score mean more negetive affects
Measured: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
mental health
The World Health Organization-Five Well-Being Index (WHO-5), higher score means better mental well-being
Measured: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups, one is control (usual care), one is VR-based multi-dimensional intervention, including LLMs, AI-agent
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GE LIN KAN, Hong Kong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064382
- Sponsor's protocol ID
- MiM20250101
- Status last verified
- Jul 2025
- First submitted
- 14 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal identity and health metrics are restricted and confidentially saved.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR-based Multi-dimensional Intervention on Cognitive Function and Well-beings
- ClinicalTrials.gov ID
- NCT07064382
- Acronym / sponsor ID
- MiM20250101
- Conditions
- Dementia, Sleepiness, Mental Health, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hong Kong University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 14 Jul 2025 (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.
Virtual Reality-based multi-dimensional intervention for cognition and well-being will be provided to older adults, with AI-agents. The digital health intervention include physical activity, gamification, cognitive trainings. Cognition, like memory, spatial function, sleepiness and mental health will be studied as outcomes.
Detailed description
In order to study the cognitive function and well-beings, qualitative methods (like questionnaires, interviews, focus groups) and quantitative methods (like ppg, ecg, eyetracker, eeg) will be used to collect data for analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups, one is control (usual care), one is VR-based multi-dimensional intervention, including LLMs, AI-agent
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –usual care |
| VR-based intervention | Experimental | Device: VR-based multi-dimensional interventionProvide VR-based multi-dimensional intervention |
Who may qualify
- Ages
- 60 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- older adults
Key exclusion criteria (2 listed)
- cannot attend physical activity like pedalling rehabilitation bike
- other health issues (assessed by health professionals)
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 |
|---|---|---|
| VR-based multi-dimensional interventionVR-based multi-dimensional intervention, including LLMs, AI-agents | Device | VR-based intervention |
Primary outcome
Spatial cognition
Time frame: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
mental rotation task,higher score means stronger spatial ability
Spatial cognition
Time frame: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
money road map test, higher score means stronger spatial ability
Spatial cognition
Time frame: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
building memory test, higher score means stronger spatial ability
Spatial cognition
Time frame: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
corsi, , higher score means stronger spatial ability
Spatial cognition
Time frame: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
digit span, higher score means stronger spatial ability
3 secondary outcomes
mental health
Time frame: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
mental health
Time frame: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
mental health
Time frame: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No. Personal identity and health metrics are restricted and confidentially saved.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing VR-based multi-dimensional intervention in people with Dementia and Sleepiness, run by Hong Kong University of Science and Technology.
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 2 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: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Spatial cognition (time frame: pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year). The study lists 5 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 14 Jul 2025.