TelemedicineNCT04820387
Assessment of Remote Vital Signs for Telemedicine Applications
An observational study of Telemedicine and Physiology, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether vital signs can be extracted from video. A secondary purpose is to create a database, including raw video, of "ground truth" physiological data on human subjects in order to test current and/or future approaches developed to extract vital signs from video. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Telemedicine, Physiology
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Adult, Older adult
Study population: Convenience
Who may be able to join
- Age: 18-75
- Fluent in English
- Normal or corrected-to-normal vision
- Able to participate in study activities
- Passed Johns Hopkins Medicine Outpatient Office COVID-19 screening checklist within 24 hours of study visit.
Who cannot join
- Hospitalization for heart failure, stroke or major cardiac event (myocardial infarction) within past 3 months.
- History of chest pain during exercise (angina).
- High blood pressure needing more than 1 medication for treatment.
- Blood pressure at rest exceeding systolic blood pressure (SBP) 150 millimeters of Mercury (mmHg), diastolic blood pressure (DBP) 100 mmHg.
- Heart rate at rest exceeding 100 beats per minute (bpm).
- Abnormal ECG, indwelling pacemaker or cardiac defibrillator.
- Home oxygen prescription.
- Women who or are pregnant or suspect they may be pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Asthma & Allergy Center
Baltimore, Maryland, 21224
About this study
The purpose of this study is to determine whether vital signs can be extracted from video. A secondary purpose is to create a database, including raw video, of "ground truth" physiological data on human subjects in order to test current and/or future approaches developed to extract vital signs from video. This research may have an immediate impact on not only the assessment of risk for COVID-19 but also may provide a significant technological enhancement to Johns Hopkins Medicine's telemedicine capabilities.
Read the detailed description
The purpose of this study is to determine whether vital signs can be extracted from video. A secondary purpose is to create a database, including raw video, of "ground truth" physiological data on human subjects in order to test current and/or future approaches developed to extract vital signs from video. This research may have an immediate impact on not only the assessment of risk for COVID-19 but also may provide a significant technological enhancement to JHM's telemedicine capabilities. Participants may be asked to:
- Complete surveys that include basic questions about participant, participant's personality, and participant's level of fitness. Participants will not be required to complete any of the surveys if participant does not feel comfortable doing so.
- Provide a subjective assessment of whether participant feels physically well enough to participate in this experiment. If participant does not feel well on a particular day and wish to participate, the research team can schedule the participant for an alternate appointment.
- Be fitted with several sensors that will measure participant's heart, participant's skin, participant's breathing, or other aspects of how participant's body is working. The sensors may be placed on participant's collarbone, below participant's ribs, on each forearm, on each ankle, and/or on participant's fingers using small stickers, medical tape, or similar means. The investigators may allow participants to place the sensors themselves under the supervision of a research team member or have the sensors placed for participants. If participant prefers, a research team member of the same sex will be available to assist sensor placement. The investigators may also place stickers or use non-permanent marker on participant's face to create clear reference points in the video.
- Complete cognitive tasks that involve viewing simple items on the screen (such as colors, shapes, letters, words, or sentences), then making decisions, such as deciding whether to press a button, whether each item matches an earlier item, or whether to remember the item or not based on a simple rule.
- Complete light to moderate exercise, such as pedaling on a stationary bicycle. The investigators will measure participant's resting heart rate, and then set a target heart rate of 20% higher for light exercise and 40% higher for moderate exercise. The American Heart Association defines moderate exercise as 50-70% of participant's maximum heart rate, which is estimated based on participant's age. To ensure a safe limit on participant's heart rate, the investigators will check that participant's target heart rates do not exceed 70% of participant's maximum estimated heart rate. If participants have health concerns about the level of exertion required, please discuss those concerns with the physician to determine whether it would be appropriate for participant to participate. Participants will only be required to make a single laboratory visit.
- Conditions
- Telemedicine, Physiology
- Keywords
- Telemedicine, Physiology, Vital Signs
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of SpO2 (percentage) from video
The principal outcome is the capability to calculate a reliable and clinically useful measure of blood oxygenation from video. Our objective is to quantify SpO2 from video within +/- 0.5% from clinical standard.
Measured: 3 years
Secondary outcomes (1)
Clinical quality data obtained via contact sensors
Develop a comprehensive dataset of ground truth physiological signals along with multiple standoff sensors against which to test current/future physiological extraction algorithms. The contact sensors will include blood pressure (BP), pulse oximetry (SpO2), photoplethysmography (PPG), respiration rate (RR), and electrocardiogram (ECG). The standoff sensors will collect still and moving images using an infrared (IR) sensor, hyperspectral imager (HSI), and multiple red-green-blue (RGB) cameras.
The dataset will be subjected to various advanced statistical analyses, to include machine learning approaches, to determine the accuracy (both in value and waveform) of algorithmic approaches to remote physiological measures. The long-term goal is to extract clinically useful physiological signals from video in order to provide a physician greater insight to the physiological functioning and/or psychophysiological state of the patient.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start20 Apr 2021
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- eMedicalSentry, Applied Physics Laboratory
- Responsible party
- Sponsor
- Investigators
- Edward Chen, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820387
- Sponsor's protocol ID
- IRB00252571
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2021
- Last updated
- 3 Sep 2026
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Remote Vital Signs for Telemedicine Applications
- ClinicalTrials.gov ID
- NCT04820387
- Acronym / sponsor ID
- IRB00252571
- Conditions
- Telemedicine, Physiology
- Keywords
- Telemedicine, Physiology, Vital Signs
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- eMedicalSentry, Applied Physics Laboratory
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Mar 2021 (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.
The purpose of this study is to determine whether vital signs can be extracted from video. A secondary purpose is to create a database, including raw video, of "ground truth" physiological data on human subjects in order to test current and/or future approaches developed to extract vital signs from video. This research may have an immediate impact on not only the assessment of risk for COVID-19 but also may provide a significant technological enhancement to Johns Hopkins Medicine's telemedicine capabilities.
Detailed description
The purpose of this study is to determine whether vital signs can be extracted from video. A secondary purpose is to create a database, including raw video, of "ground truth" physiological data on human subjects in order to test current and/or future approaches developed to extract vital signs from video. This research may have an immediate impact on not only the assessment of risk for COVID-19 but also may provide a significant technological enhancement to JHM's telemedicine capabilities. Participants may be asked to:
- Complete surveys that include basic questions about participant, participant's personality, and participant's level of fitness. Participants will not be required to complete any of the surveys if participant does not feel comfortable doing so.
- Provide a subjective assessment of whether participant feels physically well enough to participate in this experiment. If participant does not feel well on a particular day and wish to participate, the research team can schedule the participant for an alternate appointment.
- Be fitted with several sensors that will measure participant's heart, participant's skin, participant's breathing, or other aspects of how participant's body is working. The sensors may be placed on participant's collarbone, below participant's ribs, on each forearm, on each ankle, and/or on participant's fingers using small stickers, medical tape, or similar means. The investigators may allow participants to place the sensors themselves under the supervision of a research team member or have the sensors placed for participants. If participant prefers, a research team member of the same sex will be available to assist sensor placement. The investigators may also place stickers or use non-permanent marker on participant's face to create clear reference points in the video.
- Complete cognitive tasks that involve viewing simple items on the screen (such as colors, shapes, letters, words, or sentences), then making decisions, such as deciding whether to press a button, whether each item matches an earlier item, or whether to remember the item or not based on a simple rule.
- Complete light to moderate exercise, such as pedaling on a stationary bicycle. The investigators will measure participant's resting heart rate, and then set a target heart rate of 20% higher for light exercise and 40% higher for moderate exercise. The American Heart Association defines moderate exercise as 50-70% of participant's maximum heart rate, which is estimated based on participant's age. To ensure a safe limit on participant's heart rate, the investigators will check that participant's target heart rates do not exceed 70% of participant's maximum estimated heart rate. If participants have health concerns about the level of exertion required, please discuss those concerns with the physician to determine whether it would be appropriate for participant to participate. Participants will only be required to make a single laboratory visit.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Convenience
Key inclusion criteria (5 listed)
- Age: 18-75
- Fluent in English
- Normal or corrected-to-normal vision
- Able to participate in study activities
- Passed Johns Hopkins Medicine Outpatient Office COVID-19 screening checklist within 24 hours of study visit.
Key exclusion criteria (8 listed)
- Hospitalization for heart failure, stroke or major cardiac event (myocardial infarction) within past 3 months.
- History of chest pain during exercise (angina).
- High blood pressure needing more than 1 medication for treatment.
- Blood pressure at rest exceeding systolic blood pressure (SBP) 150 millimeters of Mercury (mmHg), diastolic blood pressure (DBP) 100 mmHg.
- Heart rate at rest exceeding 100 beats per minute (bpm).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantification of SpO2 (percentage) from video
Time frame: 3 years
The principal outcome is the capability to calculate a reliable and clinically useful measure of blood oxygenation from video. Our objective is to quantify SpO2 from video within +/- 0.5% from clinical standard.
1 secondary outcome
Clinical quality data obtained via contact sensors
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- 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.
Edward Chen, MD principal investigator
Johns Hopkins University
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 Telemedicine and Physiology, run by Johns Hopkins 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Quantification of SpO2 (percentage) from video (time frame: 3 years). 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 3 Sep 2026.