Alzheimer's DementiaNCT07249918
Feasibility of Wearables in Dementia Care in Rural Taiwan
A study testing Re-Timer (light therapy glasses) in people with Alzheimer's Dementia and Neuropsychiatric Symptoms Related to Neurodegenerative Disease, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Taiwan is becoming a super-aged society, and more older adults are living with Alzheimer's disease. Many people with Alzheimer's experience behavioral and psychological symptoms, such as agitation, sleep problems, or mood changes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Dementia, Neuropsychiatric Symptoms Related to Neurodegenerative Disease, Wearable Devices
- What is being tested?
- Re-Timer (light therapy glasses)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Nov 2025to 31 Dec 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For participants with dementia:
- Clinical diagnosis of probable Alzheimer's disease (AD) or mild cognitive impairment (MCI) due to AD, based on established diagnostic criteria.
- Presence of at least one prominent behavioral or psychological symptom of dementia (BPSD), including depression, agitation, apathy, or nighttime sleep disturbance.
- Prominent is defined as:
- NPI single-item score ≥ 4 (severity × frequency), or NPI-Q severity score ≥ 2, or PSQI total score ≥ 5 (if sleep disturbance is the main symptom).
- Stable living arrangement or care environment for at least two weeks before enrollment.
Show all 12Show fewer
- If receiving any pharmacological or non-pharmacological treatments for BPSD, the dosage and frequency must have remained stable for at least two weeks prior to study participation.
- Able and willing to provide informed consent; for those lacking decision-making capacity, consent must be obtained from a legally authorized representative.
- For primary caregivers:
- Adult primary caregiver of the enrolled participant.
- If receiving treatment for caregiver stress, the dosage and frequency must have been stable for at least two weeks before enrollment.
- Willing and able to provide informed consent.
Who cannot join
- Any medical condition that may increase risk during participation, including:
- Retinal disease, active use of photosensitizing medications, recent ocular surgery (within 4 weeks), or photosensitivity disorders (e.g., epilepsy).
- Unstable physical or mental condition deemed unsuitable by investigators, such as acute delirium or active respiratory infection (including COVID-19)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yueh-Heng Chiang, RN, MS. contact
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Beigang Hospital
Beigang, Yunlin, 651
Ta-Wei Guu, MD, PhD, +886-57837901, da20vid@gmail.com
Yueh-heng Chiang, RN, MS, +886-57837901, isyuehheng@gmail.com
About this study
Official title: Facilitating the Measurement and Treatment of the Behavioral Symptoms of Dementia (BPSD) and Understanding Caregiver Burden Using Wearable Devices in Rural Taiwan - A Dyadic Feasibility Pilot Study
Taiwan is becoming a super-aged society, and more older adults are living with Alzheimer's disease. Many people with Alzheimer's experience behavioral and psychological symptoms, such as agitation, sleep problems, or mood changes. These symptoms often lower their quality of life and increase stress for their family caregivers.
This study will test two wearable devices in people with Alzheimer's and their caregivers. One device, called Geneactiv, is a wristwatch that tracks daily activity and sleep. The other device, called Re-Timer, is a light therapy eyewear that may help improve sleep and mood. Researchers will look at how easy the devices are to use, whether participants are willing to wear them for several weeks, and whether the light therapy helps reduce sleep problems or caregiver stress.
The study will also compare information from questionnaires with information collected by the devices. The results may help researchers design future studies using wearable tools to better support people living with dementia and their caregivers.
Read the detailed description
Taiwan is predicted to become a super-aged society, with people older than 65 years accounting for more than 20% of the population. As the prevalence of Alzheimer's dementia (AD) increases with age, the number of people living with AD will continue to rise. Most of these individuals will experience at least one type of behavioral and psychological symptom of dementia (BPSD). These symptoms not only worsen patients' quality of life but also increase caregiver burden, leading to depression, sleep disturbances, and reduced well-being among caregivers themselves.
Currently, questionnaires completed by caregivers are the main tools used to assess and monitor BPSD. Although validated, these questionnaires can only capture cross-sectional information. In a super-aged society where many caregivers are also older adults with cognitive or physical decline, the accuracy of such assessments may be limited. Previous studies, including our research in the United Kingdom, have shown that even patients with late-stage AD can successfully wear a research-grade actigraphy device (Geneactiv) with good compliance. Device-based measurements offer continuous and objective data and can reveal valuable indicators such as the Sleep Regularity Index (SRI), which may predict both cognitive and physical function over time.
Most treatments for BPSD rely on medications, many of which are not specifically approved for this use and may increase the risk of falls or mortality. Non-pharmacological approaches, such as light-based therapy, provide a promising alternative. The Re-Timer device (an eyewear that emits blue-green light) has demonstrated effectiveness in improving sleep and mood in the general population, with a favorable safety profile. If accepted by individuals with dementia and their caregivers, such wearable devices may reduce sleep problems, agitation, and depressive symptoms, thereby improving the overall quality of life for both groups.
To date, very few studies in Taiwan have applied wearable devices to dementia care. This pilot study therefore aims to evaluate the feasibility and acceptability of two wearable technologies, the Geneactiv actigraphy and the Re-Timer light therapy glasses-among people with Alzheimer's dementia and their caregivers. Ten patient and caregiver pairs will be recruited and followed for twelve weeks. Participants will wear the Geneactiv wrist device for eight weeks and the Re-Timer glasses for four weeks. Sleep quality, behavioral symptoms, caregiver burden, and user experience will be assessed through both questionnaires and device data.
The primary goal is to determine whether dementia patients and caregivers can safely and consistently use these devices. Secondary goals include exploring the preliminary effects of Re-Timer on sleep and BPSD, comparing traditional questionnaire results with digital measurements, and establishing a foundation for future large-scale studies to develop digital biomarkers and technology-assisted interventions for dementia care in Taiwan.
- Conditions
- Alzheimer's Dementia, Neuropsychiatric Symptoms Related to Neurodegenerative Disease, Wearable Devices, Caregiver Burden of People With Dementia, Circadian Rhythm
- Being tested
- Re-Timer (light therapy glasses)
- Keywords
- Wearable device, behavioural and psychological symptoms of dementia (BPSD), Sleep, Alzheimer's dementia, Caregiver Burden
- Medical subject headings
- Alzheimer Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-Timer (light therapy glasses)Device
an eyewear emitting specific wavelength of green light.
| Study group | Role | What they receive |
|---|---|---|
| Re-Timer (light therapy glasses) | Experimental | an eyewear emitting specific wavelength of green light. Receives: Device: Re-Timer (light therapy glasses) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
As measured by Pittsburgh Sleep Quality Index (PSQI), a questionnaire providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: baseline to week 12.
Actigraphy-Derived Sleep and Circadian Rhythm Variables
Device-based sleep and circadian rhythm data will be collected via Geneactiv actigraphy and analyzed using the GGIR open-source algorithm. Key variables include:
- Sleep-related: sleep onset time, wake-up time, total sleep duration (hours), sleep efficiency (%), and wake after sleep onset (WASO, minutes).
- Circadian-related: light exposure (lux), M5/L5 (activity amplitude), mean sleep midpoint (MSA), intradaily variability (IV), interdaily stability (IS), daytime napping, and Sleep Regularity Index (SRI).
These will be summarized as descriptive statistics and examined for longitudinal change.
Measured: From enrollment to the end of trial at 8 weeks
Feasibility and Acceptability of Device-Based Interventions
The feasibility, compliance, and satisfaction of using Geneactiv (for measurement) and Re-Timer (for intervention) will be evaluated through qualitative interviews, device adherence data, and the Quebec User Evaluation of Satisfaction with Assistive Technology - Taiwanese version (QUEST-TW).
Measured: From enrollment to the end of trial (12 weeks)
Secondary outcomes (2)
Caregiver Burden
As measured by Caregiver Burden Inventory (CBI). A 24-item self-report scale assessing five dimensions of caregiver burden (time-dependence, developmental, physical, social, and emotional). The total score ranges from 0 to 96, where higher scores indicate greater burden.
Measured: Baseline to Week 12.
Behavioral and Psychological Symptoms of Dementia (BPSD)
As measured by Neuropsychiatric Inventory Questionnaire (NPI-Q), which evaluates 12 domains of neuropsychiatric symptoms. Each item is rated for severity (0-3) and distress (0-5), producing a total score range of 0-36 for severity and 0-60 for distress, where higher scores indicate greater symptom severity.
Measured: Baseline to Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start18 Nov 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DementiaStudies of the same condition, open and under way.
- More trials run by China Medical University 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
- Not applicable
- Intervention model
- Single group
- Model description
- single arm dyadic pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ta-wei Guu, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249918
- Sponsor's protocol ID
- CMUH114-REC3-072
- Status last verified
- Feb 2026
- First submitted
- 14 Nov 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will decide if the IPD can be shared before the end of the study.
Publications
Guu TW, Aarsland D, Ffytche D. Light, sleep-wake rhythm, and behavioural and psychological symptoms of dementia in care home patients: Revisiting the sundowning syndrome. Int J Geriatr Psychiatry. 2022 May;37(5):10.1002/gps.5712. doi: 10.1002/gps.5712.
PubMed 35470491Guu TW, Brem AK, Albertyn CP, Kandangwa P, Aarsland D, Ffytche D. Wrist-worn actigraphy in agitated late-stage dementia patients: A feasibility study on digital inclusion. Alzheimers Dement. 2024 May;20(5):3211-3218. doi: 10.1002/alz.13772. Epub 2024 Mar 18.
PubMed 38497216
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating the Measurement and Treatment of the Behavioral Symptoms of Dementia (BPSD) and Understanding Caregiver Burden Using Wearable Devices in Rural Taiwan - A Dyadic Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT07249918
- Acronym / sponsor ID
- CMUH114-REC3-072
- Conditions
- Alzheimer's Dementia, Neuropsychiatric Symptoms Related to Neurodegenerative Disease, Wearable Devices, Caregiver Burden of People With Dementia, Circadian Rhythm
- Keywords
- Wearable device, behavioural and psychological symptoms of dementia (BPSD), Sleep, Alzheimer's dementia, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Nov 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.
Taiwan is becoming a super-aged society, and more older adults are living with Alzheimer's disease. Many people with Alzheimer's experience behavioral and psychological symptoms, such as agitation, sleep problems, or mood changes. These symptoms often lower their quality of life and increase stress for their family caregivers.
This study will test two wearable devices in people with Alzheimer's and their caregivers. One device, called Geneactiv, is a wristwatch that tracks daily activity and sleep. The other device, called Re-Timer, is a light therapy eyewear that may help improve sleep and mood. Researchers will look at how easy the devices are to use, whether participants are willing to wear them for several weeks, and whether the light therapy helps reduce sleep problems or caregiver stress.
The study will also compare information from questionnaires with information collected by the devices. The results may help researchers design future studies using wearable tools to better support people living with dementia and their caregivers.
Detailed description
Taiwan is predicted to become a super-aged society, with people older than 65 years accounting for more than 20% of the population. As the prevalence of Alzheimer's dementia (AD) increases with age, the number of people living with AD will continue to rise. Most of these individuals will experience at least one type of behavioral and psychological symptom of dementia (BPSD). These symptoms not only worsen patients' quality of life but also increase caregiver burden, leading to depression, sleep disturbances, and reduced well-being among caregivers themselves.
Currently, questionnaires completed by caregivers are the main tools used to assess and monitor BPSD. Although validated, these questionnaires can only capture cross-sectional information. In a super-aged society where many caregivers are also older adults with cognitive or physical decline, the accuracy of such assessments may be limited. Previous studies, including our research in the United Kingdom, have shown that even patients with late-stage AD can successfully wear a research-grade actigraphy device (Geneactiv) with good compliance. Device-based measurements offer continuous and objective data and can reveal valuable indicators such as the Sleep Regularity Index (SRI), which may predict both cognitive and physical function over time.
Most treatments for BPSD rely on medications, many of which are not specifically approved for this use and may increase the risk of falls or mortality. Non-pharmacological approaches, such as light-based therapy, provide a promising alternative. The Re-Timer device (an eyewear that emits blue-green light) has demonstrated effectiveness in improving sleep and mood in the general population, with a favorable safety profile. If accepted by individuals with dementia and their caregivers, such wearable devices may reduce sleep problems, agitation, and depressive symptoms, thereby improving the overall quality of life for both groups.
To date, very few studies in Taiwan have applied wearable devices to dementia care. This pilot study therefore aims to evaluate the feasibility and acceptability of two wearable technologies, the Geneactiv actigraphy and the Re-Timer light therapy glasses-among people with Alzheimer's dementia and their caregivers. Ten patient and caregiver pairs will be recruited and followed for twelve weeks. Participants will wear the Geneactiv wrist device for eight weeks and the Re-Timer glasses for four weeks. Sleep quality, behavioral symptoms, caregiver burden, and user experience will be assessed through both questionnaires and device data.
The primary goal is to determine whether dementia patients and caregivers can safely and consistently use these devices. Secondary goals include exploring the preliminary effects of Re-Timer on sleep and BPSD, comparing traditional questionnaire results with digital measurements, and establishing a foundation for future large-scale studies to develop digital biomarkers and technology-assisted interventions for dementia care in Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm dyadic pilot study
| Arm | Type | Receives |
|---|---|---|
| Re-Timer (light therapy glasses) | Experimental | Device: Re-Timer (light therapy glasses)an eyewear emitting specific wavelength of green light. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- For participants with dementia:
- NPI single-item score ≥ 4 (severity × frequency), or NPI-Q severity score ≥ 2, or PSQI total score ≥ 5 (if sleep disturbance is the main symptom).
- For primary caregivers:
Key exclusion criteria (3 listed)
- Any medical condition that may increase risk during participation, including:
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 |
|---|---|---|
| Re-Timer (light therapy glasses)an eyewear emitting specific wavelength of green light. | Device | Re-Timer (light therapy glasses) |
Primary outcome
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
Time frame: baseline to week 12.
As measured by Pittsburgh Sleep Quality Index (PSQI), a questionnaire providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Actigraphy-Derived Sleep and Circadian Rhythm Variables
Time frame: From enrollment to the end of trial at 8 weeks
Device-based sleep and circadian rhythm data will be collected via Geneactiv actigraphy and analyzed using the GGIR open-source algorithm. Key variables include: * Sleep-related: sleep onset time, wake-up time, total sleep duration (hours), sleep efficiency (%), and wake after sleep onset (WASO, minutes). * Circadian-related: light exposure (lux), M5/L5 (activity amplitude), mean sleep midpoint (MSA), intradaily variability (IV), interdaily stability (IS), daytime napping, and Sleep Regularity Index (SRI). These will be summarized as descriptive statistics and examined for longitudinal change.
Feasibility and Acceptability of Device-Based Interventions
Time frame: From enrollment to the end of trial (12 weeks)
The feasibility, compliance, and satisfaction of using Geneactiv (for measurement) and Re-Timer (for intervention) will be evaluated through qualitative interviews, device adherence data, and the Quebec User Evaluation of Satisfaction with Assistive Technology - Taiwanese version (QUEST-TW).
2 secondary outcomes
Caregiver Burden
Time frame: Baseline to Week 12.
Behavioral and Psychological Symptoms of Dementia (BPSD)
Time frame: Baseline to Week 12.
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 11 Feb 2026.
- Results publication: PubMed 35470491Guu TW, Aarsland D, Ffytche D. Light, sleep-wake rhythm, and behavioural and psychological symptoms of dementia in care home patients: Revisiting the sundowning syndrome. Int J Geriatr Psychiatry. 2022 May;37(5):10.1002/gps.5712. doi: 10.1002/gps.5712.
- Results publication: PubMed 38497216Guu TW, Brem AK, Albertyn CP, Kandangwa P, Aarsland D, Ffytche D. Wrist-worn actigraphy in agitated late-stage dementia patients: A feasibility study on digital inclusion. Alzheimers Dement. 2024 May;20(5):3211-3218. doi: 10.1002/alz.13772. Epub 2024 Mar 18.
- Individual participant dataSharing planned: Undecided. We will decide if the IPD can be shared before the end of the study.
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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.
Yueh-Heng Chiang, RN, MS. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-Timer (light therapy glasses) in people with Alzheimer's Dementia and Neuropsychiatric Symptoms Related to Neurodegenerative Disease, run by China Medical University 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 12 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: looking for participants now, as of the sponsor's last update on 11 Feb 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. 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 Dr Ta-Wei Guu Consultant psychiatrist, MD, PhD (05783790, 066753@tool.caaumed.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI) (time frame: baseline to week 12.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07249918, which also lists 2 linked publications.
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 11 Feb 2026.