COVID-19NCT05334680
International Validation of Wearable Sensor to Monitor COVID-19 Like Signs and Symptoms
An observational study of COVID-19, run by Arun Jayaraman, PT, PhD at 3 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- ANNE Sensor
- Type of treatment
- Medical device
- How many people
- 550 participants
- Where
- 3 sitesIndia
- Study dates
- 24 Jun 2021to 31 Dec 2023
- 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
- Healthy volunteers accepted
- 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 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.
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
3 sites in 1 country.
India3 sites
Induss Hospitals
Hyderabad, Telangana, 500035
St. Georges Hospital
Mumbai, Maharashtra, 400001
Lifepoint Multi-Specialty Hospital
Pune, Maharashtra, 411057
About this study
Official title: Wearable Sensor to Monitor and Track COVID-19-like Signs and Symptoms to Develop Better Care Strategies for COVID-19 Pandemic - An Exploratory Study
- Deploy wearable COVID sensor to collect high resolution physiological data (temperature, cardiac, respiratory and physical activity) from COVID positive patients.
- Use collected data to train algorithm for assessing the risk of individuals presenting with symptoms suggestive of COVID-19.
- Conditions
- COVID-19
- Being tested
- ANNE Sensor
- Keywords
- Wearable sensor, Machine learning, COVID-19
- 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 SensorDevice
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: ANNE Sensor | |
| Healthy Controls | Individuals without any known significant health problems Receives: Device: ANNE Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Instantaneous heart rate associated with various activity levels
Measured: Baseline; Possible reassessment up to five days after consent
Respiratory frequency
Participants will be asked to breathe normally before and after walking for 30 seconds.
Measured: Baseline; Possible reassessment up to five days after consent
Cough Frequency
Cough signal characteristics during five consecutive coughs
Measured: Baseline; Possible reassessment up to five days after consent
Body temperature
Periodic temperature readings throughout the activity sequence
Measured: Baseline; Possible reassessment up to five days after consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start24 Jun 2021
- Primary completion8 Mar 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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.
- 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
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arun Jayaraman, PT, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- United States - India Science and Technology Endowment Fund, Northwestern University, Induss Hospitals, Bionic Yantra, Clinfinite Solutions, Indian Institute of Technology Kharagpur
- Responsible party
- Sponsor-investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334680
- Sponsor's protocol ID
- BY/001/2021
- Status last verified
- Jan 2023
- First submitted
- 15 Apr 2022
- Last updated
- 19 Jan 2023
- 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 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Sensor to Monitor and Track COVID-19-like Signs and Symptoms to Develop Better Care Strategies for COVID-19 Pandemic - An Exploratory Study
- ClinicalTrials.gov ID
- NCT05334680
- Acronym / sponsor ID
- BY/001/2021
- Conditions
- COVID-19
- Keywords
- Wearable sensor, Machine learning, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Arun Jayaraman, PT, PhDUniversity, hospital or other
- Collaborators
- United States - India Science and Technology Endowment Fund, Northwestern University, Induss Hospitals, Bionic Yantra, Clinfinite Solutions, Indian Institute of Technology Kharagpur
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 8 Mar 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Apr 2022 (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.
- Deploy wearable COVID sensor to collect high resolution physiological data (temperature, cardiac, respiratory and physical activity) from COVID positive patients.
- Use collected data to train algorithm for assessing the risk of individuals presenting with symptoms suggestive of COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Device: ANNE SensorIndividuals experiencing COVID-19 like symptoms. |
| Healthy Controls | – | Device: ANNE SensorIndividuals without any known significant health problems |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- 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 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.
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 |
|---|---|---|
| ANNE SensorThe 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
Heart Rate
Time frame: Baseline; Possible reassessment up to five days after consent
Instantaneous heart rate associated with various activity levels
Respiratory frequency
Time frame: Baseline; Possible reassessment up to five days after consent
Participants will be asked to breathe normally before and after walking for 30 seconds.
Cough Frequency
Time frame: Baseline; Possible reassessment up to five days after consent
Cough signal characteristics during five consecutive coughs
Body temperature
Time frame: Baseline; Possible reassessment up to five days after consent
Periodic temperature readings throughout the activity sequence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
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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, PT, PhD principal investigator
Shirley Ryan AbilityLab
3 sites 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, run by Arun Jayaraman, PT, PhD at 3 sites in India.
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: status not confirmed, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. 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?
Results are not available in the source record.
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?
Heart Rate (time frame: Baseline; Possible reassessment up to five days after consent). 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 19 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.