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OpenTrials
Completed

NCT Number: NCT04362631

Respiratory Infection Monitoring

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Efficacy of wearable device to detect respiratory infection parameters: cough count

    Time frame: 1 year

    Device data measuring cough count. Captured by analysis of peak acclerometer graphing and duration in meters per second squared (m/s2).

  2. Monitoring of respiratory infection symptoms, WURSS-11 Survey

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2020
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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