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International Validation of Wearable Sensor to Monitor COVID-19 Like Signs and Symptoms

Wearable Sensor to Monitor and Track COVID-19-like Signs and Symptoms to Develop Better Care Strategies for COVID-19 Pandemic - An Exploratory Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05334680
Enrollment
550
Registered
2022-04-19
Start date
2021-06-24
Completion date
2023-12-31
Last updated
2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Wearable sensor, Machine learning, COVID-19

Brief summary

1. Deploy wearable COVID sensor to collect high resolution physiological data (temperature, cardiac, respiratory and physical activity) from COVID positive patients. 2. Use collected data to train algorithm for assessing the risk of individuals presenting with symptoms suggestive of COVID-19.

Interventions

DEVICEANNE Sensor

The data collected from this sensor contains a wide range of core and novel respiratory digital biomarkers as a home-based early identification system. The core measurements include: heart rate, heart rate variability, temperature, physical activity (including sleep quality) and respiratory rate. The novel respiratory digital biomarkers include: respiratory cadence (expiration / inspiration time), coughing, swallowing, throat clearing, and talk time.

Sponsors

United States - India Science and Technology Endowment Fund
CollaboratorUNKNOWN
Northwestern University
CollaboratorOTHER
Induss Hospitals
CollaboratorUNKNOWN
Bionic Yantra
CollaboratorUNKNOWN
Clinfinite Solutions
CollaboratorNETWORK
Indian Institute of Technology Kharagpur
CollaboratorUNKNOWN
Arun Jayaraman, PT, PhD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes

Inclusion criteria

* Ages between 18-95 years old * Currently experiencing any COVID-like signs and symptoms such as fever, cough, shortness of breath, trouble breathing, persistent pain or pressure in the chest, confusion or inability to arouse, bluish lips or face. * Individuals who are not experiencing any COVID like signs and symptoms (will be asked to be healthy control) * Able and willing to give written consent and comply with study procedures.

Exclusion criteria

* Inability to understand instructions and follow a three step command. * The subject is pregnant, nursing or planning a pregnancy. * Inability to provide written consent.

Design outcomes

Primary

MeasureTime frameDescription
Heart RateBaseline; Possible reassessment up to five days after consentInstantaneous heart rate associated with various activity levels
Respiratory frequencyBaseline; Possible reassessment up to five days after consentParticipants will be asked to breathe normally before and after walking for 30 seconds.
Cough FrequencyBaseline; Possible reassessment up to five days after consentCough signal characteristics during five consecutive coughs
Body temperatureBaseline; Possible reassessment up to five days after consentPeriodic temperature readings throughout the activity sequence

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026