Wearable-enhanced Intervention for Elderly Depression and Sleep Disturbance - From Feasibility and Efficacy, to Development of the First Taiwanese Wearable-embedded Elderly Prospective Research Cohort
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Sleep and Circadian Rhythm
研究概览
简要总结
This 4-year study aims to develop a safe and effective management model for late-life depression using wearable technologies. The research will recruit older adults (aged 60 and above) with major depressive disorder, confirmed by DSM-5 criteria.
In the first phase, participants will wear a research-grade actigraphy device (Geneactiv) for at least four weeks to assess its usability and accuracy compared with traditional questionnaires. In later phases, a double-blind randomized clinical trial will evaluate the efficacy of a photobiomodulation (PBM) headband in improving depressive and sleep symptoms.
The project will also establish Taiwan's first longitudinal database integrating wearable data, clinical symptoms, and biological markers, aiming to identify digital phenotypes and predictive biomarkers for elderly depression. The study is expected to advance precision psychiatry and digital health applications in geriatric mental health care.
详细描述
By 2025, Taiwan will become a super-aged society, with a rapidly growing number of older adults living with depression and related sleep problems. Late-life depression is often underdiagnosed and undertreated, and current assessments rely heavily on self-reported or clinician-rated questionnaires, which only provide snapshots of symptoms and may not accurately reflect daily variations in mood and sleep. These challenges highlight the urgent need for more objective, continuous, and accessible tools to monitor and manage depression in older adults.
Wearable devices, such as actigraphy and photobiomodulation (PBM), offer new opportunities for both assessment and intervention. Actigraphy can provide objective data on sleep-wake cycles, activity levels, and circadian rhythms, while PBM uses near-infrared light to modulate brain activity and improve mood and sleep quality. Building on our previous collaboration with Harvard University and recent findings from wearable PBM trials, this project seeks to establish an integrated, technology-assisted model for managing late-life depression in Taiwan.
This four-year project will begin by validating the feasibility and acceptability of a research-grade actigraphy device (Geneactiv) among older adults diagnosed with major depressive disorder (MDD). Objective activity and sleep data will be compared with questionnaire-based assessments to evaluate reliability and consistency, forming the foundation for Taiwan's first longitudinal wearable-based geriatric depression database.
In the second and third years, the study will conduct a double-blind, randomized, sham-controlled clinical trial to evaluate the safety and effectiveness of a wearable PBM headband device in improving depressive symptoms and sleep quality. Participants will continue their regular treatments while using the PBM device at home for daily sessions.
In the final year, longitudinal data from actigraphy, PBM intervention, clinical evaluations, and biological markers will be analyzed to identify digital phenotypes and predictive biomarkers associated with depression severity, treatment response, and functional outcomes. The long-term goal is to establish a comprehensive digital mental health platform that integrates biological, behavioral, and clinical dimensions, providing a scalable model for improving geriatric mental health in Taiwan's aging population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Major Depressive Disorder (MDD), either single or recurrent episode.
- •Have a Hamilton Depression Rating Scale (HAM-D, 17-item) total score of 14 or higher at baseline.
- •Participants who are currently taking medications that may affect mood, sleep, or circadian rhythms (e.g., antidepressants, sedative antipsychotics, or sleep aids) may be included, provided that the dosage has remained stable for at least two weeks prior to enrollment.
- •Prior to inclusion, informed consent must be obtained. If cognitive impairment prevents subjects from signing, consent may be obtained from their primary caregiver (who may be a legal or professional representative).
排除标准
- •Diagnosis of dementia of any severity, bipolar disorder, psychotic disorder, psychotic episode, or substance use disorder.
- •Active suicidal ideation or suicide attempt within the past three months.
- •Any other conditions deemed unsuitable for participation by the clinical physician, such as:
- •Currently experiencing acute delirium.
- •Suffering from respiratory infections, including COVID-
- •Participants with significant skin conditions on the head or conditions that could affect the efficacy of light therapy will be excluded. These include cases with:
- •Hemangiomas.
- •Scleroderma.
- •Psoriasis.
- •Open wounds.
- •Tattoos on the head. Additionally, individuals with head implants or those who have undergone photosensitizing drug treatments within two weeks prior to trial participation will also be excluded.
研究组 & 干预措施
Photobiomodulation
Participants allocated to this arm will receive photobiomodulation for up to 8 weeks, using a wearable headband.
干预措施: Photobiomodulation (Device)
sham
Participants allocated to this arm will not receive photobiomodulation for up to 8 weeks, using a sham wearable headband.
干预措施: Sham (No Treatment) (Device)
结局指标
主要结局
Sleep and Circadian Rhythm
时间窗: 8 weeks post-treatment.
Sleep and circadian rhythm will be assessed using both questionnaire-based and device-based approaches. The questionnaire-based component will employ the Pittsburgh Sleep Quality Index (PSQI), which provides a total score ranging from 0 to 21, with lower scores indicating better sleep quality. The device-based component will analyze data from Geneactiv, processed with the validated open-source GGIR algorithm. 1. Five sleep variables will be derived: sleep onset time, wake-up time, total sleep duration, sleep efficiency, and wake after sleep onset (WASO). 2. Seven circadian rhythm variables will also be analyzed: light exposure amount and timing, M5/L5 (five-hour periods of highest/lowest activity), mean sleep midpoint time (MSA), intra-daily variability (IV), inter-daily stability (IS), daytime napping, and the Sleep Regularity Index (SRI).
Depression
时间窗: 8 weeks post-treatment.
Depression severity will be assessed using both questionnaire-based and device-based approaches. The questionnaire-based component will employ the depression severity assessed using the Hamilton Depression Rating Scale (HAM-D, 17-item version) which provides a total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. The device-based behavioral correlates (e.g., daytime activity, sleep fragmentation, light exposure regularity) derived from Geneactiv actigraphy will be analyzed to explore relationships with depressive symptom changes. Qualitative interviews will supplement quantitative findings to explore patient-reported mood changes and subjective well-being during the trial.
Feasibility, Acceptability, and User Experience of Device-Based Measurement and Management
时间窗: From enrollment to the end of trial at 12 weeks
Feasibility, satisfaction, and user experience with Geneactiv actigraphy and near-infrared photobiomodulation devices will be evaluated using: Quantitative assessments - Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST, Taiwanese version), compliance rate (measured by device-wearing duration and adherence), and completion rate of scheduled assessments. Qualitative interviews - conducted post-intervention to capture participants' experiences, perceived usability, and barriers to adoption. Data will be analyzed thematically to identify key factors affecting acceptability and implementation.
次要结局
未报告次要终点
研究者
Ta-wei Guu
Consultant Psychiatrist
China Medical University Hospital