COVID-19NCT04393558
Wearable Sensor to Monitor COVID-19 Like Signs and Symptoms
An observational study of COVID-19 and Healthy Control, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
1. Develop a wearable sensor package to gather data on COVID-19-like signs and symptoms such as elevated body temperature, respiratory parameters, heart rate ,cough and gait. 2. Create algorithms to monitor and track changes to COVID19-like signs and symptoms for developing a better care and isolation strategies for… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- COVID-19, Healthy Control
- What is being tested?
- ADAM Sensor
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2020to 26 Oct 2020
- 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 to 95 years
- All sexes
- Adult, Older adult
Study population: Individuals who may have experienced COVID-19 like symptoms.
Who may be able to join
- 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 experience 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.
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.
Trial locations and contacts
1 site in 1 country.
About this study
- Develop a wearable sensor package to gather data on COVID-19-like signs and symptoms such as elevated body temperature, respiratory parameters, heart rate ,cough and gait.
- Create algorithms to monitor and track changes to COVID19-like signs and symptoms for developing a better care and isolation strategies for COVID-19 pandemic.
Read the detailed description
Aim 1:
Each enrolled participant will be asked to wear the sensor on a daily basis. Duration of the participation varies based on the symptom severity. With the currently available information, recovery times are ranging from 7 days to 56 days. The duration of the study participation can begin at the early detection to all the way until complete recovery or discharge. Participants may be asked to use the sensors anywhere from 7 days to 60 days. Duration of study will be based on the participant's self-reported symptoms or as appropriate determined by the PI. This will allow the research team to collect a comprehensive data set that can characterize both COVID-like and non-COVID-like signs and symptoms.
Aim 2:
Data collected from Aim#1 will aid in generating machine learning algorithms to characterize the signs and symptoms. Further algorithm development will be carried out to develop signs and symptoms progression and regression models for early warning or warning to prevent return to work of health-care staff or civilians
Wearable sensors are compact battery powered miniature electronic devices that are attached to a user's body to record physiological, biochemical and physical activity information. Different types of sensors can be used to monitor these digital biomarkers. Inertial measurement units (IMUs), including accelerometers, gyroscopes, magnetometers are typically used to measure physical activity, movement signatures. Miniature temperature, galvanic skin response (GSR), photoplethysmogram (PPG), oxygen saturation (SPO2) sensors are increasingly embedded in wearable devices for vital sign monitoring. Non-invasive monitoring is very ideal in the current pandemic situation. These sensors can be potentially deployed in large scale to monitor cases of suspected infection and patients recovering from COVID-19.
This project is planning to develop a sensor system that is capable of gathering data on COVID-19 like symptoms such as cough, body temperature, respiratory parameters. Machine algorithms will be developed to handle data analysis and derive useful clinical and monitor signs and symptoms in cases of suspected infection and individuals actively recovering from COVID-19 like symptoms
- Conditions
- COVID-19, Healthy Control
- Being tested
- ADAM Sensor
- Keywords
- Wearable sensor, COVID-19, Machine learning
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAM SensorDevice
ADAM 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.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Individuals experiencing COVID-19 like symptoms. Receives: Device: ADAM Sensor | |
| Healthy Controls | Individuals without any known significant health problems Receives: Device: ADAM Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
Body temperature : Periodic temperature readings over the day (every 15 minutes)
Measured: Minimum 7 days from day 1 of study enrollment up to 60 days
Cough Frequency
Number of coughing episodes in an hour
Measured: Minimum 7 days from day 1 of study enrollment up to 60 days
Respiratory frequency
Number of breaths per minute
Measured: Minimum 7 days from day 1 of study enrollment up to 60 days
Heart Rate Instantaneous heart rate every 15 minutes.
Instantaneous heart rate every 15 minutes
Measured: Minimum 7 days from day 1 of study enrollment up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start20 Apr 2020
- Primary completion26 Oct 2020
- Study completion26 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393558
- Sponsor's protocol ID
- STU00212522
- Status last verified
- Apr 2025
- First submitted
- 16 May 2020
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Sensor to Monitor COVID-19 Like Signs and Symptoms
- ClinicalTrials.gov ID
- NCT04393558
- Acronym / sponsor ID
- STU00212522
- Conditions
- COVID-19, Healthy Control
- Keywords
- Wearable sensor, COVID-19, Machine learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 19 May 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.
- Develop a wearable sensor package to gather data on COVID-19-like signs and symptoms such as elevated body temperature, respiratory parameters, heart rate ,cough and gait.
- Create algorithms to monitor and track changes to COVID19-like signs and symptoms for developing a better care and isolation strategies for COVID-19 pandemic.
Detailed description
Aim 1:
Each enrolled participant will be asked to wear the sensor on a daily basis. Duration of the participation varies based on the symptom severity. With the currently available information, recovery times are ranging from 7 days to 56 days. The duration of the study participation can begin at the early detection to all the way until complete recovery or discharge. Participants may be asked to use the sensors anywhere from 7 days to 60 days. Duration of study will be based on the participant's self-reported symptoms or as appropriate determined by the PI. This will allow the research team to collect a comprehensive data set that can characterize both COVID-like and non-COVID-like signs and symptoms.
Aim 2:
Data collected from Aim#1 will aid in generating machine learning algorithms to characterize the signs and symptoms. Further algorithm development will be carried out to develop signs and symptoms progression and regression models for early warning or warning to prevent return to work of health-care staff or civilians
Wearable sensors are compact battery powered miniature electronic devices that are attached to a user's body to record physiological, biochemical and physical activity information. Different types of sensors can be used to monitor these digital biomarkers. Inertial measurement units (IMUs), including accelerometers, gyroscopes, magnetometers are typically used to measure physical activity, movement signatures. Miniature temperature, galvanic skin response (GSR), photoplethysmogram (PPG), oxygen saturation (SPO2) sensors are increasingly embedded in wearable devices for vital sign monitoring. Non-invasive monitoring is very ideal in the current pandemic situation. These sensors can be potentially deployed in large scale to monitor cases of suspected infection and patients recovering from COVID-19.
This project is planning to develop a sensor system that is capable of gathering data on COVID-19 like symptoms such as cough, body temperature, respiratory parameters. Machine algorithms will be developed to handle data analysis and derive useful clinical and monitor signs and symptoms in cases of suspected infection and individuals actively recovering from COVID-19 like symptoms
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Device: ADAM SensorIndividuals experiencing COVID-19 like symptoms. |
| Healthy Controls | – | Device: ADAM SensorIndividuals without any known significant health problems |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals who may have experienced COVID-19 like symptoms.
Key inclusion criteria (4 listed)
- 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 experience 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.
Key exclusion criteria (3 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.
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 |
|---|---|---|
| ADAM SensorADAM 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. | Device | COVID-19, Healthy Controls |
Primary outcome
Body temperature
Time frame: Minimum 7 days from day 1 of study enrollment up to 60 days
Body temperature : Periodic temperature readings over the day (every 15 minutes)
Cough Frequency
Time frame: Minimum 7 days from day 1 of study enrollment up to 60 days
Number of coughing episodes in an hour
Respiratory frequency
Time frame: Minimum 7 days from day 1 of study enrollment up to 60 days
Number of breaths per minute
Heart Rate Instantaneous heart rate every 15 minutes.
Time frame: Minimum 7 days from day 1 of study enrollment up to 60 days
Instantaneous heart rate every 15 minutes
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 17 Apr 2025.
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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.
Arun Jayaraman, PhD principal investigator
Shirley Ryan AbilityLab
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 COVID-19 and Healthy Control, run by Shirley Ryan AbilityLab 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 4 inclusion and 3 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 17 Apr 2025. 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?
Body temperature (time frame: Minimum 7 days from day 1 of study enrollment up to 60 days). The study lists 4 primary outcomes in all. 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 17 Apr 2025.