Feasibility of Wearables in Dementia Care in Rural Taiwan
Recruiting · NCT07249918 · Interventional (participants receive a specific treatment) · Lead sponsor: China Medical University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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)
Where it is running
1 location listed.
- China Medical University Beigang Hospital - Beigang, Yunlin, Taiwan