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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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

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

Other trials in United States

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.
Keywords
Telemedicine, Physiology, Vital Signs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted29 Mar 2021
  2. Study start20 Apr 2021
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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)
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

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