Smart Brain Health Promotion Service Integrating Personalized Sensory Stimulation: Practical Validation and Application in Urban and Rural Dementia Care Centers
| Registry | NCT07778277 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 90 (Estimated) |
| Sponsor | Chang Gung Memorial Hospital (Other) |
| Conditions | Dementia, Acoustic Stimulation, Healthcare Disparities, Precision Medicine, Cognitive Training |
| Interventions | Digital personalized intervention system (active setting), Gamma auditory stimulation device (active setting), Gamma auditory stimulation device (sham setting) (Device) |
| Dates | start 2026-09-20 (estimated), primary completion 2026-09-20 (estimated), completion 2028-09-20 (estimated), first posted 2026-08-21, last updated 2026-08-21 |
| Locations | 1 site in Taiwan |
Related Papers Related Patents Related Grants Related Experts
All trials for Dementia All trials for Acoustic Stimulation All trials of Digital personalized intervention system (active setting) All trials of Gamma auditory stimulation device (active setting)
As Taiwan transitions into a super-aged society, rising dementia rates have severely strained long-term care systems. Although current daycare centers provide multi-modal programs, they remain limited to behavioral training, lacking precise interventions targeting brain function and neuroplasticity or integrated non-invasive neuromodulation technologies. Furthermore, urban-rural disparities in resources, staffing allocation, and tech experience hinder practical deployment, with empirical research remaining scarce. Addressing this gap, this study investigates a smart brain health promotion model combining personalized gamma music stimulation and cognitive training for mild cognitive impairment and dementia, while evaluating its feasibility across diverse care settings.
As Taiwan transitions into a super-aged society, the prevalence of dementia continues to rise, and its associated behavioral and psychological symptoms have placed a significant burden on the long-term care system. While current adult daycare centers and dementia care center have widely adopted multi-modal health promotion programs-which offer certain benefits for functional maintenance-they largely focus on behavioral training levels. They rarely incorporate precise intervention designs that directly act on brain function and neuroplasticity, nor do they integrate safe, low-invasive brain neuromodulation technologies suitable for long-term care settings.
Furthermore, differences in resource conditions, staffing allocation, and technological experience across different care settings (such as urban versus rural areas) pose challenges to the practical promotion and application of long-term care technology, with relevant empirical research remaining relatively limited.
To address these research gaps, this study combines personalized gamma music stimulation with cognitive activity training to investigate their effects on cognitive performance and psychological states in older adults with mild cognitive impairment and mild dementia. Additionally, it evaluates the feasibility and acceptability of different intervention tools across various care settings, serving as an empirical reference for the development of smart brain health promotion models.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Urban High-Tech Experimental Group | Experimental | Device: Digital personalized intervention system (active setting) | This intervention includes music and personalized gamma auditory stimulation, delivered via a digital intervention system in urban daycare centers. |
| Urban Low-Tech Experimental Group | Experimental | Device: Gamma auditory stimulation device (active setting) | This intervention includes music and personalized gamma auditory stimulation, delivered via earphones in urban daycare centers. |
| Urban Control Group | Sham comparator | Device: Gamma auditory stimulation device (sham setting) | This intervention includes only music and is delivered via earphones in urban daycare centers. |
| Rural High-Tech Experimental Group | Experimental | Device: Digital personalized intervention system (active setting) | This intervention includes music and personalized gamma auditory stimulation, delivered via a digital intervention system in rural daycare centers. |
| Rural Low-Tech Experimental Group | Experimental | Device: Gamma auditory stimulation device (active setting) | is intervention includes music and personalized gamma auditory stimulation, delivered via earphones in rural daycare centers. |
| Rural Control Group | Sham comparator | Device: Gamma auditory stimulation device (sham setting) | This intervention includes only music and is delivered via earphones in rural daycare centers. |
Sex: All, ages: 60 Years to any
Inclusion Criteria: * Aged ≥ 60 years * The score of MoCA between 10 to 25 Exclusion Criteria: * Diagnosis of other psychiatric or neurological disorders, and those with a history of neurological or psychiatric disorders that may affect cognitive assessment or performance. For example (but not limited to): Parkinson's disease, schizophrenia, major depressive disorder, epilepsy, severe traumatic brain injury with loss of consciousness, and stroke. * Drug, Nicotine or alcohol addictions * Serious heart, liver or kidney disorders, and visual, auditory or motor impairments interfering with neuropsychological tests.
| Facility | City | Country | Status |
|---|---|---|---|
| Chang Gung University | Taoyuan, Guishan | Taiwan |