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NCT04362631 | COMPLETED | Chronic Obstructive Pulmonary Disease (COPD)

Respiratory Infection Monitoring
Sponsor:

Northwestern University

Information provided by (Responsible Party):

Ankit Bharat

Brief Summary:

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

Condition or disease

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
Estimated Enrollment : 42 participants
Official Title : Advanced, Bio-Integrated, and Cloud-Enabled Sensors for Early Diagnosis of Respiratory Infections in the Home Setting
Actual Study Start Date : 2020-04-24
Estimated Primary Completion Date : 2022-09-06
Estimated Study Completion Date : 2022-09-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Respiratory Infection Monitoring

Location Details

NCT04362631

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Illinois

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611