Respiratory Infection Monitoring

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04362631
• Other study ID #: STU00210701
• Status: Completed
• Start date: April 24, 2020
• Est. completion date: September 6, 2022

Study information

• Verified date: February 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 6, 2022
• Est. primary completion date: September 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Tract Infections

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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