Respiratory Infection Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-24

Study Completion Date

2022-09-06

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults

Adults 18 years or older

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No