NCT07249918 Feasibility of Wearables in Dementia Care in Rural Taiwan
| NCT ID | NCT07249918 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China Medical University Hospital |
| Condition | Alzheimer's Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-11-18 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-11-18 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * For participants with dementia: 1. Clinical diagnosis of probable Alzheimer's disease (AD) or mild cognitive impairment (MCI) due to AD, based on established diagnostic criteria. 2. Presence of at least one prominent behavioral or psychological symptom of dementia (BPSD), including depression, agitation, apathy, or nighttime sleep disturbance. 3. 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). 4. Stable living arrangement or care environment for at least two weeks before enrollment. 5. 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. 6. 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: 1. Adult primary caregiver of the enrolled participant. 2. If receiving treatment for caregiver stress, the dosage and frequency must have been stable for at least two weeks before enrollment. 3. Willing and able to provide informed consent. Exclusion Criteria: * Any medical condition that may increase risk during participation, including: 1. Retinal disease, active use of photosensitizing medications, recent ocular surgery (within 4 weeks), or photosensitivity disorders (e.g., epilepsy). 2. Unstable physical or mental condition deemed unsuitable by investigators, such as acute delirium or active respiratory infection (including COVID-19)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07249918 clinical trial?
This trial is open to participants of all sexes, studying Alzheimer's Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07249918 currently recruiting?
Yes, NCT07249918 is actively recruiting participants. Contact the research team at 066753@tool.caaumed.org.tw for enrollment information.
Where is the NCT07249918 trial being conducted?
This trial is being conducted at Beigang, Taiwan.
Who is sponsoring the NCT07249918 clinical trial?
NCT07249918 is sponsored by China Medical University Hospital. The trial plans to enroll 20 participants.
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