Clinical trial NCT04362631: Respiratory Infection Monitoring
Official title: Advanced, Bio-Integrated, and Cloud-Enabled Sensors for Early Diagnosis of Respiratory Infections in the Home Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2020-04-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults

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

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.

Eligibility 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.

Primary outcomes:
measure: Efficacy of wearable device to detect respiratory infection parameters: cough count
timeFrame: 1 year
measure: Monitoring of respiratory infection symptoms, WURSS-11 Survey
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Shuai Xu
role: PRINCIPAL_INVESTIGATOR
References: