Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
This study will monitor physical bio-markers such as heart rate, respiratory rate, and temperature to detect potential respiratory infections.
Detailed description
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.
Interventions
None listed
Sponsors
Department of Health and Human Services
Northwestern University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of wearable device to detect respiratory infection parameters: cough count | 1 year | Device data measuring cough count. Captured by analysis of peak acclerometer graphing and duration in meters per second squared (m/s2). |
| Monitoring of respiratory infection symptoms, WURSS-11 Survey | 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). |
Countries
United States
Outcome results
None listed