DementiaNCT07778277
Personalized Sensory Stimulation: Urban and Rural Dementia Care
A study testing Digital personalized intervention system (active setting) and Gamma auditory stimulation device (active setting) in people with Dementia and Acoustic Stimulation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Acoustic Stimulation, Healthcare Disparities
- What is being tested?
- Digital personalized intervention system (active setting) and Gamma auditory stimulation device (active setting)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Sep 2026to 20 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 60 years
- The score of MoCA between 10 to 25
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Chang Gung University
Taoyuan, Guishan, 333
Chia-Hsiung Cheng, Ph.D., +886-3-211800 ext. 3854, ch.cheng@mail.cgu.edu.tw
About this study
Official title: Smart Brain Health Promotion Service Integrating Personalized Sensory Stimulation: Practical Validation and Application in Urban and Rural Dementia Care Centers
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.
Read the detailed description
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.
- Conditions
- Dementia, Acoustic Stimulation, Healthcare Disparities, Precision Medicine, Cognitive Training
- Being tested
- Digital personalized intervention system (active setting), Gamma auditory stimulation device (active setting), Gamma auditory stimulation device (sham setting)
- Keywords
- Dementia, Gamma frequency auditory tone, Personalize intervention, Urban-rural disparities, Cognitive training
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital personalized intervention system (active setting)Device
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.
Gamma auditory stimulation device (active setting)Device
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.
Gamma auditory stimulation device (sham setting)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Urban High-Tech Experimental Group | Experimental | This intervention includes music and personalized gamma auditory stimulation, delivered via a digital intervention system in urban daycare centers. Receives: Device: Digital personalized intervention system (active setting) |
| Urban Low-Tech Experimental Group | Experimental | This intervention includes music and personalized gamma auditory stimulation, delivered via earphones in urban daycare centers. Receives: Device: Gamma auditory stimulation device (active setting) |
| Urban Control Group | Sham comparator | This intervention includes only music and is delivered via earphones in urban daycare centers. Receives: Device: Gamma auditory stimulation device (sham setting) |
| Rural High-Tech Experimental Group | Experimental | This intervention includes music and personalized gamma auditory stimulation, delivered via a digital intervention system in rural daycare centers. Receives: Device: Digital personalized intervention system (active setting) |
| Rural Low-Tech Experimental Group | Experimental | is intervention includes music and personalized gamma auditory stimulation, delivered via earphones in rural daycare centers. Receives: Device: Gamma auditory stimulation device (active setting) |
| Rural Control Group | Sham comparator | This intervention includes only music and is delivered via earphones in rural daycare centers. Receives: Device: Gamma auditory stimulation device (sham setting) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change score of Montreal Cognitive Assessment (MoCA)
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.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2)
Secondary outcomes (5)
Change score of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
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.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2)
Change score of the Neuropsychiatric Inventory Questionnaire (NPI-Q)
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.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2)
Change score of the Geriatric Depression Scale-15 (GDS-15).
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.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2)
User Subjective Experience Assessment
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).
Measured: Through intervention completion, an average of 3 month (T2)
Qualitative Interview
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.
Measured: Through intervention completion, an average of 3 month (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 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.
- More trials run by Chang Gung Memorial HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778277
- Sponsor's protocol ID
- 202600129B0A3
- Status last verified
- Mar 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Brain Health Promotion Service Integrating Personalized Sensory Stimulation: Practical Validation and Application in Urban and Rural Dementia Care Centers
- ClinicalTrials.gov ID
- NCT07778277
- Acronym / sponsor ID
- 202600129B0A3
- Conditions
- Dementia, Acoustic Stimulation, Healthcare Disparities, Precision Medicine, Cognitive Training
- Keywords
- Dementia, Gamma frequency auditory tone, Personalize intervention, Urban-rural disparities, Cognitive training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2028 (estimated)
- First posted
- 21 Aug 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥ 60 years
- The score of MoCA between 10 to 25
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Digital personalized intervention system (active setting)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. | Device | Rural High-Tech Experimental Group, Urban High-Tech Experimental Group |
| Gamma auditory stimulation device (active setting)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. | Device | Rural Low-Tech Experimental Group, Urban Low-Tech Experimental Group |
| Gamma auditory stimulation device (sham setting)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. | Device | Rural Control Group, Urban Control Group |
Primary outcome
Change score of Montreal Cognitive Assessment (MoCA)
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.
5 secondary outcomes
Change score of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2)
Change score of the Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2)
Change score of the Geriatric Depression Scale-15 (GDS-15).
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2)
User Subjective Experience Assessment
Time frame: Through intervention completion, an average of 3 month (T2)
Qualitative Interview
Time frame: Through intervention completion, an average of 3 month (T2)
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 21 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital personalized intervention system (active setting) and Gamma auditory stimulation device (active setting) in people with Dementia and Acoustic Stimulation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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 21 Aug 2026. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Contact Chia-Hsiung Cheng, Ph.D. (+886-3-211800 ext. 3854, ch.cheng@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change score of Montreal Cognitive Assessment (MoCA) (time frame: baseline (T1), through intervention completion, an average of 3 month (T2)). 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 21 Aug 2026.