Feasibility of Wearables in Dementia Care in Rural Taiwan

NCT07249918 | Recruiting

• 1 other identifier: CMUH114-REC3-072
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropsychiatric Symptoms Related to Neurodegenerative Disease; Alzheimer's Dementia; 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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  From enrollment to the end of trial (12 weeks)

Secondary Outcomes (2)

• Caregiver Burden

  Baseline to Week 12.

• Behavioral and Psychological Symptoms of Dementia (BPSD)

  Baseline to Week 12.

Other Outcomes (4)

• Patient Baseline Characteristics

  Baseline (Day 0)

• Caregiver Baseline Characteristics

  Baseline (Day 0)

• Patient Cognitive Assessment

  Baseline (Day 0).

Study Arms (1)

Re-Timer (light therapy glasses)

EXPERIMENTAL

an eyewear emitting specific wavelength of green light.

Device: Re-Timer (light therapy glasses)

Interventions

Re-Timer (light therapy glasses) DEVICE

an eyewear emitting specific wavelength of green light.

Re-Timer (light therapy glasses)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Beigang Hospital

Beigang, Yunlin, 651, Taiwan

RECRUITING

Related Publications (2)

• 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.

  PMID: 35470491 RESULT

• Guu 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.

  PMID: 38497216 RESULT

MeSH Terms

Conditions

Alzheimer Disease; Caregiver Burden

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Dr Ta-Wei Guu Consultant psychiatrist, MD, PhD

CONTACT

05783790; 066753@tool.caaumed.org.tw

Yueh-Heng Chiang, RN, MS.

CONTACT

isyuehheng@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Psychiatrist

Model Details: single arm dyadic pilot study

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 25, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

TW (1)