Clinical Evaluation of the Capability of SenseGuard™ Non-invasive Wearable Device, to Detect Respiratory Changes, During Home Monitoring of Subjects With High Susceptibility for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 6
- 主要终点
- Significant changes in SenseGuard device respiratory parameters (Ratio of Inhalation to exhalation time) can indicate for early exacerbation of COPD patient.
研究概览
简要总结
This is an observational, open labeled study. The study aims to evaluate the capability of SenseGuard™ (SG) non-invasive wearable device, to detect, post-hoc, early respiratory changes due to exacerbation by daily monitoring of subjects with COPD, at home.
Subjects with COPD, that were discharged following hospitalization due to AECOPD are most susceptible to experience another exacerbation during the first 6 months post admission. Hence, subjects that were discharged from the hospital due to AECOPD during the last 3 months are eligible to the study.
详细描述
During the study subject will be monitored daily for up to 6 months. Subject will perform 2 daily measurements of tidal breathing with SG, for 8 minutes each. Measurements are performed at the same time window every day; in the morning, before any treatment, and in the evening.
Monitoring will be continued during exacerbations and hospitalization if and when occurred.
Subject will complete a weekly online COPD symptoms assessment questionnaire, sent by email or a text massage.
Subject will report the clinical team about any increase of respiratory symptoms that may lead to exacerbation. Subject will get treatment for confirmed exacerbation according to the Standard of Care. Each case of symptoms and/or confirmed exacerbation will be documented in the CRF and reported to NanoVation team within 24 hours from onset. The daily data obtained by SG, prior to the exacerbation, will be analyzed to detect early respiratory change associated with this exacerbation. This information is critical for SG data interpretation and for the development of early alert for AECOPD.
NanoVation team will provide all subjects with the following: training to use SG, technical support in any case of a problem with the device and reminders to use the SG in case of reduced compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥
- •Diagnosed with COPD, 30%< FEV1 <80% predicated, or FEV1>80% and FEV1/FVC < 0.7
- •Discharged from the hospital during the last 3 months due to AECOPD.
- •Provision of signed and dated informed consent form.
- •Speak, read and understand either Hebrew, Arabic or English.
- •Able to understand study requirements and comply with study procedures.
- •Able to operate a tablet for SG measurement.
排除标准
- •Suffer from any physical or cognitive impairment that may affect subject's capability to operate the SG device properly.
- •Pregnant woman or nursing mother.
- •Severely ill with less than 12-month life expectancy
- •Suffering from serious uncontrolled medical conditions that may interfere with study requirements.
- •Participated in another clinical study during the study period, that may interrupt their participation in this study.
研究组 & 干预措施
Investigational SenseGuard Device
All subjects use SenseGuard Device for twice daily monitoring of respiratory parameters.
干预措施: SenseGuard Investigational Device (Device)
结局指标
主要结局
Significant changes in SenseGuard device respiratory parameters (Ratio of Inhalation to exhalation time) can indicate for early exacerbation of COPD patient.
时间窗: 6 months
60% of confirmed COPD exacerbations can be detected in post-hoc analysis of changes in tidal breathing parameters measured by SenseGuard™ (significant change from baseline of Ratio of Inhalation to Exhalation time).
次要结局
- Rate of retention and Compliance of COPD patients who use SG for home monitoring(6 months)