Advanced, Bio-Integrated, and Cloud-Enabled Sensors for Early Diagnosis of Respiratory Infections in the Home Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Monitoring of respiratory infection symptoms, WURSS-11 Survey
研究概览
简要总结
This study will monitor physical bio-markers such as heart rate, respiratory rate, and temperature to detect potential respiratory infections.
详细描述
The advanced, bio-integrated wireless sensor (ADAM) that provides a comprehensive assessment of cardiopulmonary health. The technology employs advanced low-power operation, in-sensor analytics, and cloud integration. The sensor's novel soft mechanics allows for comfortable placement on the suprasternal notch, a location of unique anatomical importance, to collect both core vitals (heart rate, respiratory rate, temperature, and physical activity including sleep quality) and novel respiratory digital biomarkers (cough count, swallowing, throat clearing and respiratory effort). The investigators will deploy this system in a cohort of high-risk patients for respiratory infection in a home setting to predict for respiratory infections prior to clinical deterioration.
The investigators aim to capture data on 122 study subjects over the course of 52 weeks of continuous wear or the investigator's device to thoroughly characterize physiological data and diagnosis of respiratory infections. Data from standard of care appointments, diagnostic testing or imaging, or treatment will be collected from the patient medical record to validate device data.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Outpatient at start of the study
- •Established clinical history of COPD
- •Previous hospital or ICU admission for pneumonia or COPD
- •Active corticosteroid prescription
- •Willingness to participate in the study (long term continuous wear of the device)
- •Ability to apply and remove devices and use a mobile application
排除标准
- •Mental or neurodegenerative disease
- •Including a current diagnosis of asthma, respiratory disorders (e.g. active tuberculosis, lung cancer, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases); pneumonia or other RTIs not resolved ≤14 days or ≤7 days, respectively, prior to screening
- •Skin condition or wound on suprasternal notch.
结局指标
主要结局
Monitoring of respiratory infection symptoms, WURSS-11 Survey
时间窗: 1 year
WURSS-11 survey. https://www.fammed.wisc.edu/files/webfm-uploads/documents/research/wurss-11.pdf The WURSS-11 survey will be conducted on a weekly basis by study subjects for the duration of the study (up to 52 weeks).
Efficacy of wearable device to detect respiratory infection parameters: cough count
时间窗: 1 year
Device data measuring cough count. Captured by analysis of peak acclerometer graphing and duration in meters per second squared (m/s2).
次要结局
未报告次要终点
研究者
Ankit Bharat
Principal Investigator
Northwestern University