Vital Sensor Monitors for CV19 Detection | NCT04635787

Studies
Vital Sensor Monitors for CV19 Detection

NCT04635787

Sponsor

Northwestern University

Status

Completed

Last Update Posted

May 6, 2023Actual

Enrollment

324Actual

Phase

Not provided

Conditions

Covid19

Interventions

ANNE One

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2020Actual

Primary Completion Date

Mar 31, 2021Actual

Completion Date

Aug 31, 2021Actual

First Submitted Date

Nov 13, 2020

First Submission Date that Met QC Criteria

Nov 18, 2020

First Posted Date

Nov 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2023

Last Update Posted Date

May 6, 2023Actual

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

324Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Adults		Adults 18 years or older	Device: ANNE One
COVID19		Adults 18 years or older diagnosed with COVID 19	Device: ANNE One

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ANNE One	Device	Wireless vital sign monitoring device	COVID19 Healthy Adults

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1.Efficacy of wearable device to detect respiratory infection parameters: cough count	Device data measuring cough count. Captured by analysis of peak acclerometer graphing and duration in meters per second squared (m/s2).	1 year

Secondary Outcomes

Measure	Description	Time Frame
2.Monitoring of respiratory infection symptoms, WURSS-11 Survey	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).	Time Frame: 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy adults and adults exposed to or diagnosed with COVID19

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern Memorial Hospital		Chicago	Illinois	60611	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided