Vital Sensor Monitors for CV19 Detection

NCT ID: NCT04635787

Last Updated: 2023-05-06

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

324 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-05

Study Completion Date

2021-08-31

Brief Summary

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This study will monitor physical bio-markers such as heart rate, respiratory rate, and temperature to detect potential COVID-19 infections.

Detailed Description

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The purpose of this research is to assess the accuracy of wearable sensors at detecting and monitoring COVID-19 infections. Our small, wearable sensor can get data on your respiration, body temperature, heart rate, and blood oxygen level, which may help physicians better identify if a respiratory condition is worsening overtime. If successful, our sensor could help healthcare professionals detect early symptoms of COVID-19 respiratory infection and monitor recovery and treat people before their condition worsens significantly.

Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Adults

Adults 18 years or older

ANNE One

Intervention Type DEVICE

Wireless vital sign monitoring device

COVID19

Adults 18 years or older diagnosed with COVID 19

ANNE One

Intervention Type DEVICE

Wireless vital sign monitoring device

Interventions

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ANNE One

Wireless vital sign monitoring device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 years old or over
* Recent (within 1 week) occupational or home exposure to a newly diagnosed COVID-19 infected individual
* 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
* Past confirmed COVID-19 infection with resolution of symptoms
* Past confirmed COVID-19 active infection moderate or severe symptoms
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Shuai (Steve) Xu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00213040

Identifier Type: -

Identifier Source: org_study_id

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