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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
an eyewear emitting specific wavelength of green light.
China Medical University Beigang Hospital
Beigang, Yunlin, Taiwan
RECRUITINGSleep 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.
Time frame: 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.
Time frame: 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).
Time frame: From enrollment to the end of trial (12 weeks)
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.
Time frame: 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.
Time frame: Baseline to Week 12.
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