Respiratory Infection Monitoring

Advanced, Bio-Integrated, and Cloud-Enabled Sensors for Early Diagnosis of Respiratory Infections in the Home Setting

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

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.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

• Study Contact: Name: Dermatology CTU; Phone Number: 312-503-5944; Email: DermSensors@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adults; Adults 18 years or older

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of wearable device to detect respiratory infection parameters: cough count	Device data measuring cough count. Captured by analysis of peak acclerometer graphing and duration in meters per second squared (m/s2).	1 year
Monitoring of respiratory infection symptoms, WURSS-11 Survey	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).	1 year

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Department of Health and Human Services

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2020
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Infections
• Other Study ID Numbers: STU00210701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No