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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Taiwan
China Medical University Beigang Hospital
RECRUITING
Beigang
Contact Information
Primary
Dr Ta-Wei Guu Consultant psychiatrist, MD, PhD
066753@tool.caaumed.org.tw
05783790
Backup
Yueh-Heng Chiang, RN, MS.
isyuehheng@gmail.com
Time Frame
Start Date: 2025-11-18
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Re-Timer (light therapy glasses)
an eyewear emitting specific wavelength of green light.
Related Therapeutic Areas
Sponsors
Leads: China Medical University Hospital

This content was sourced from clinicaltrials.gov