Covid19NCT04635787
Vital Sensor Monitors for CV19 Detection
An observational study of Covid19, run by Northwestern University at 1 site in United States.
Trial summary
This study will monitor physical bio-markers such as heart rate, respiratory rate, and temperature to detect potential COVID-19 infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- ANNE One
- Type of treatment
- Medical device
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Healthy adults and adults exposed to or diagnosed with COVID19
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: ICU-Grade Wearable Sensors With Novel Respiratory Biomarkers to Diagnose and Detect Pre- and Very Early Symptomatic COVID-19 Infection Using Predictive Machine Learning Algorithms
This study will monitor physical bio-markers such as heart rate, respiratory rate, and temperature to detect potential COVID-19 infections.
Read the 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.
- Conditions
- Covid19
- Being tested
- ANNE One
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANNE OneDevice
Wireless vital sign monitoring device
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Adults 18 years or older Receives: Device: ANNE One | |
| COVID19 | Adults 18 years or older diagnosed with COVID 19 Receives: Device: ANNE One |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (1)
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).
Measured: Time Frame: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start5 Nov 2020
- Primary completion31 Mar 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Shuai (Steve) Xu, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635787
- Sponsor's protocol ID
- STU00213040
- Status last verified
- May 2023
- First submitted
- 13 Nov 2020
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU-Grade Wearable Sensors With Novel Respiratory Biomarkers to Diagnose and Detect Pre- and Very Early Symptomatic COVID-19 Infection Using Predictive Machine Learning Algorithms
- ClinicalTrials.gov ID
- NCT04635787
- Acronym / sponsor ID
- STU00213040
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | – | Device: ANNE OneAdults 18 years or older |
| COVID19 | – | Device: ANNE OneAdults 18 years or older diagnosed with COVID 19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy adults and adults exposed to or diagnosed with COVID19
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANNE OneWireless vital sign monitoring device | Device | COVID19, Healthy Adults |
Primary outcome
1.Efficacy of wearable device to detect respiratory infection parameters: cough count
Time frame: 1 year
Device data measuring cough count. Captured by analysis of peak acclerometer graphing and duration in meters per second squared (m/s2).
1 secondary outcome
2.Monitoring of respiratory infection symptoms, WURSS-11 Survey
Time frame: Time Frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Efficacy of wearable device to detect respiratory infection parameters: cough count (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.