Respiratory Infection Monitoring

Northwestern University

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04362631

STU00210701

Details and patient eligibility

About

This study will monitor physical bio-markers such as heart rate, respiratory rate, and temperature to detect potential respiratory infections.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

42 participants in 1 patient group

Adults

Description:

Adults 18 years or older