Early Prediction of Acute Exacerbations of COPD Using Wearable and Portable Remote Monitoring Technology With AI/ML Empowered Platforms: A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood oxygen saturation (SpO2) prior oscillometry test
研究概览
简要总结
This study is aimed to collect real-time physiological data using two wearable devices (a biometric ring and a biometric wristband), daily lung mechanical measurements by a handheld oscillometer, and participant-reported symptoms in patients with COPD remotely from their home environment. The data will be used to train and validate artificial intelligence and machine learning (AI/ML) models to predict COPD exacerbations in advance of their actual occurrence. The data will also be used to test the new severity classification system for exacerbations of COPD, as well as to determine important relationships between physiological measurements from the wearable devices, the handheld oscillometer, the self-reported symptoms, and the tests performed at the baseline visit.
详细描述
A single-site, prospective, observational cohort study to collect high-quality multidimensional data from the wearable/portable devices, as well as symptom and exacerbation data, in high-risk patients with frequent exacerbations in order to develop a COPD exacerbation predictive model.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males/females, age ≥ 40, former/current smokers with ≥10 pack-year smoking history
- •FEV1/FVC < 0.7, with 80% < FEV1 ≤50% (moderate, 'GOLD 2') 50% < FEV1 ≤ 30% (severe, 'GOLD 3') or FEV1 < 30% (very severe, 'GOLD 4') COPD
- •History of 2 or more exacerbations in the preceding 12 months requiring corticosteroids, antibiotics, or both
- •Ability to provide informed consent
- •Ability to access internet at least once daily
排除标准
- •No existing COPD diagnosis
- •Any medical/cognitive/functional condition which renders inability to operate research equipment/devices, and/or to complete daily symptom response
结局指标
主要结局
Blood oxygen saturation (SpO2) prior oscillometry test
时间窗: Daily for 12 months
Parameter measured with handheld oscillometry before performing oscillometry test.
Minute ventilation (Ve)
时间窗: Daily for 12 months
Parameter measured with handheld oscillometry, related to lung mechanics/function.
Respiration
时间窗: Daily/nightly for 12 months
Respiratory rate (RR) and respiratory rate variability (RRV) measured with wearable devices
Step count
时间窗: Daily/nightly for 12 months
Parameter measured with wearable devices, related to activity.
Cardiovascular
时间窗: Daily/nightly for 12 months
Heart rate (HR) and HR variability (HRV) measured with wearable devices
Oxygen level
时间窗: Daily/nightly for 12 months
Blood oxygen saturation (SpO2) measured with wearable devices
Sleep duration
时间窗: Nightly for 12 months
Parameter measured with wearable devices.
Reactance at 5 Hz (X5)
时间窗: Daily for 12 months
Parameter measured at 5 Hz frequency with handheld oscillometry, related to lung mechanics/function.
Respiratory flows
时间窗: Daily for 12 months
Inspiratory and expiratory flows measured with handheld oscillometry, related to lung mechanics/function.
Respiratory rate (RR)
时间窗: Daily for 12 months
Parameter measured with handheld oscillometry.
Metabolic equivalents
时间窗: Daily/nightly for 12 months
Parameter measured with wearable devices, related to activity.
Sleep efficiency
时间窗: Nightly for 12 months
Parameter measured with wearable devices.
Sleep oncet
时间窗: Nightly for 12 months
Parameter measured with wearable devices.
Heart rate (HR) prior oscillometry test
时间窗: Daily for 12 months
Parameter measured with handheld oscillometry before performing oscillometry test.
Daily symptom questionnaire
时间窗: Daily for 12 months
• Visual analog scale (VAS) scores for dyspnea, sputum volume, sputum purulence, cough, wheeze, and fatigue, scaled 0-10. Higher scores indicate worse symptoms.
Calories
时间窗: Daily/nightly for 12 months
Parameter measured with wearable devices, related to activity.
Sleep disturbance
时间窗: Nightly for 12 months
Parameter measured with wearable devices.
Body temperature
时间窗: Nightly for 12 months
Peripheral body temperature measured with wearable devices
Resistance at 5 Hz (R5)
时间窗: Daily for 12 months
Parameter measured at 5 Hz frequency with handheld oscillometry, related to lung mechanics/function.
Weekly exacerbation questionnaire
时间窗: Weekly for 12 months
• Self report on any exacerbation(s) which occurred in the preceding week and their date(s), whether/how the exacerbation was treated, and in what treatment setting.
Rapid eye movement (REM) sleep
时间窗: Nightly for 12 months
Parameter measured with wearable devices.
Deep sleep
时间窗: Nightly for 12 months
Parameter measured with wearable devices.
Intra-breath difference between expiratory and inspiratory reactance (ΔXrs)
时间窗: Daily for 12 months
Parameter measured with handheld oscillometry, related to lung mechanics/function.
Tidal volume (Vt)
时间窗: Daily for 12 months
Parameter measured with handheld oscillometry, related to lung mechanics/function.
Movement intensity
时间窗: Daily/nightly for 12 months
Parameter measured with wearable devices, related to activity.
次要结局
- 6-Minute Walk Test (6MWT)(Once (baseline visit))
- System Usability Scale (SUS)(Through study completion, 1 year.)
- COPD Assessment Test (CAT)(Once (baseline visit))
研究者
Bryan A. Ross
Clinician-Scientist (RI-MUHC), Respirologist (MUHC), Assistant Professor (McGill University)
McGill University Health Centre/Research Institute of the McGill University Health Centre