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.
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.
Stable living arrangement or care environment for at least two weeks before enrollment.
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.
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)
Single group
Re-Timer (light therapy glasses)
Devicean eyewear emitting specific wavelength of green light.
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.
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.
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).
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.
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.
Patient Baseline Characteristics
Includes age (year/month of birth), sex, marital status, education (years), age at AD/MCI diagnosis, time since BPSD onset, smoking and alcohol use, medical/psychiatric comorbidities, and current treatments.
Caregiver Baseline Characteristics
Includes age (year/month of birth), sex, marital status, education (years), smoking and alcohol use, medical/psychiatric comorbidities, and current treatments.
Patient Cognitive Assessment
Cognitive staging assessed using one validated instrument: CDR (0-5), MMSE (0-30), CASI (0-100), or MoCA (0-30). The most recent assessment within 6 months will be used; reassessment performed if decline is suspected.
Caregiver Cognitive Screening (If Applicable)
For older caregivers or those suspected of decline, cognitive screening will be assessed using CDR (0-5), CASI (0-100), MMSE (0-30), or MoCA (0-30). The most recent assessment within 6 months will be used; reassessment performed if decline is suspected.
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