NCT07064382

Brief 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. Cognition, like memory, spatial function, sleepiness and mental health will be studied as outcomes.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Jul 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Jul 2025Jun 2028

First Submitted

Initial submission to the registry

June 14, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2028

Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

2.9 years

First QC Date

June 14, 2025

Last Update Submit

July 3, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Spatial cognition

    mental rotation task,higher score means stronger spatial ability

    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

    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

    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

    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

    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

    pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year

  • mental health

    pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year

  • mental health

    pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year

Other Outcomes (1)

  • Sleepiness

    pre-intervention, after 4 weeks, 8 weeks, 12 weeks, 16 weeks, 3 months, 6 months, 1 year, 2 year, 3 year

Study Arms (2)

control

NO INTERVENTION

usual care

VR-based intervention

EXPERIMENTAL

Provide VR-based multi-dimensional intervention

Device: VR-based multi-dimensional intervention

Interventions

VR-based multi-dimensional intervention, including LLMs, AI-agents

VR-based intervention

Eligibility Criteria

Age60 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older adults

You may not qualify if:

  • cannot attend physical activity like pedalling rehabilitation bike
  • other health issues (assessed by health professionals)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DementiaSleepinessPsychological Well-BeingAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehaviorTauopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups, one is control (usual care), one is VR-based multi-dimensional intervention, including LLMs, AI-agent
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 14, 2025

First Posted

July 14, 2025

Study Start

July 15, 2025

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

June 15, 2028

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Personal identity and health metrics are restricted and confidentially saved.