Chang Gung University
Taoyuan, Guishan, 333, Taiwan
NCT Number: NCT07778277
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.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Taoyuan, Guishan, 333, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive auditory stimulation using the gamma auditory stimulation device (active setting) during cognitive training activity for 1 hour per day, 2 days a week, over 12 weeks, for a total of 24 hours.
Participants will receive auditory stimulation using the gamma auditory stimulation device (active setting) during cognitive training activity for 1 hour per day, 2 days a week, over 12 weeks, for a total of 24 hours.
Participants will receive auditory stimulation using the gamma auditory stimulation device (sham setting) during cognitive training activity for 1 hour per day, 2 days a week, over 12 weeks, for a total of 24 hours.
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2)
This scale is one of the most commonly used tools for assessing mild cognitive impairment and early-stage dementia, evaluating capacities such as executive function, attention, visuospatial abilities, language, memory, and orientation. The scale has a maximum score of 30, with higher scores indicating better cognitive function.
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2)
A neuropsychological test used to assess cognitive impairment, particularly in the context of Alzheimer's disease. The ADAS-Cog typically has a total score ranging from 0 to 70, with higher scores indicating greater cognitive impairment.
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2)
Through semi-structured interviews with primary caregivers or observers, this scale will be used to assess behavioral and psychological symptoms of dementia (BPSD). It consists of 12 items, including depression, anxiety, agitation, hallucinations, delusions, insomnia, behavioral problems, and emotional instability. Each item is scored in two parts: frequency (1 = rarely, 2 = sometimes, 3 = often, 4 = very often/almost daily) and severity (1 = mild, 2 = moderate, 3 = severe). The symptom score for each item equals frequency multiplied by severity (ranging from 0 to 12 points). The total score of the scale ranges from 0 to 144, with higher scores indicating more severe symptoms.
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2)
This scale assesses the depressive emotional states of older adults through self-administration or interviews, covering dimensions such as motivation for activity participation, social and life satisfaction, energy levels, fatigue, and feelings of sadness or hopelessness. It consists of 15 items, with each item scored 0 or 1 (0 = No, 1 = Yes); higher scores indicate a more severe level of depression.
Time frame: Through intervention completion, an average of 3 month (T2)
We will collect subjective assessments from participants and the staff in daycare center across three dimensions: intervention acceptability, system usability, and overall satisfaction. Each dimension will be evaluated using a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).
Time frame: Through intervention completion, an average of 3 month (T2)
Using purposive sampling, we will invite willing older adults and care workers with good attendance from each experimental group (anticipating 2 older adults and 2 care workers per group, totaling approximately 16 participants) to conduct semi-structured in-depth interviews. Each interview will last approximately 30 to 60 minutes, and will be audio-recorded with the participants' consent for subsequent transcription. The main topics will include: (1) overall impressions and acceptability of the intervention program; (2) subjective experiences regarding gamma music and technological devices; (3) setting- and resource-related factors; (4) gender- and personal background-related experiences; (5) practical implementation challenges faced by care workers and their coping strategies; and (6) recommendations for future program adjustments and scaling. Qualitative data will be analyzed using thematic analysis with the qualitative analysis software ATLAS.ti.
Contact information is provided by the study sponsor or research team.
Chang Gung Memorial Hospital
Other
Smart Brain Health Promotion Service Integrating Personalized Sensory Stimulation: Practical Validation and Application in Urban and Rural Dementia Care Centers
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