NCT04763746: VISION-MD

The Measurement of VItal SIgns by Lifelight® Software in comparisON to the Standard of Care - Multi-site Development

Completed Last updated 26 January 2024

What this trial tests

trial testing Lifelight Data Collect Sub-protocol 1 in Respiratory Disorder in 1,869 participants. Completed in 1 April 2023.

Timeline

1 June 2021

Primary endpoint
14 April 2022

1 April 2023

Quick facts

Lead sponsor	Xim Limited
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,869
Start date	1 June 2021
Primary completion	14 April 2022
Estimated completion	1 April 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Lifelight Data Collect Sub-protocol 1
• Lifelight Data Collect Sub-protocol 2
• Lifelight Data Collect Sub-protocol 3
• Lifelight Data Collect Sub-protocol 4

Conditions studied

• Respiratory Disorder — all drugs for Respiratory Disorder →
• Diabetes — all drugs for Diabetes →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Critical Care — all drugs for Critical Care →

Sponsor

Xim Limited

Who can join

16 and older, any sex, with Respiratory Disorder or Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

AIM: To advance the development and accuracy of the Lifelight® app for the measurement of vital signs, therefore developing a non-invasive and easy-to-perform means of measuring vital signs which can be implemented across a wide range of settings, both within hospitals and out in the community.

METHOD: Lifelight® is a computer program ("app") for measuring vital signs which can be used on smart devices that contain a camera. It is able to measure all of the vital signs by measuring very small changes in skin colour that occur each time the heart beats. This means that it does not need to touch the patient. The investigators believe this could be an effective way of measuring vital signs, especially during the COVID-19 pandemic when prevention of cross-contamination between patients is essential. Patients are also likely to be reassured by a contactless approach. The app uses data from looking at a person's face to calculate the vital signs. This is possible because there are tiny changes in facial skin that occur each time the heart beats.

The investigators believe Lifelight® could be an effective way of measuring vital signs. The app is still under development, which means that it is still "learning" the best match between the information it collects from the face and the values of vital signs measured using the standard equipment. The app should become more accurate in calculating the vital signs as it sees more and more information from patients.

So far, the app has seen data from inpatients, outpatients, patients attending GP surgeries and healthy people. This has improved its accuracy in measuring vital signs. However, the app needs to see more information so that it can be sufficiently accurate for specific clinical applications such as long-term monitoring of hypertension. To do this, it particularly needs to see information from people with abnormal blood pressures and blood oxygen levels. In order to capture the full range of observations, the app will need to be trialled with some of the most critically ill patients - some of these will not have capacity to consent to participation in the study. It also needs to see more data from people with different skin tones so the investigators can be sure it is accurate for all patients.

To do this, the investigators will recruit people who are attending one of two hospitals, either as an inpatient, an outpatient, a friend/relative of a patient, or a member of hospital staff. The exact number will depend on how quickly the app "learns" and how many of the vital signs are outside of the normal range. The investigators will take the participant's vital signs using standard clinical equipment whilst recording a video of their face. The investigators will use most of these measurements and video to teach the app how to become more accurate at measuring vital signs. The investigators will keep the remaining data separate and use it to test how accurate the app is. All of the data will be kept securely.

The investigators will also collect feedback from participants and healthcare staff on their experiences using the app and information that allows us to assess whether there are any savings to the healthcare economy through use of this technology.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Measurement of Vital Signs Using Lifelight Remote Photoplethysmography: Results of the VISION-D and VISION-V Observational Studies.
   Heiden E, Jones T, Brogaard Maczka A, Kapoor M, et al · · 2022 · cited 9× · PMID 36374541 · DOI 10.2196/36340
2. Measurement of Vital Signs by Lifelight Software in Comparison to Standard of Care Multisite Development (VISION-MD): Protocol for an Observational Study.
   Wiffen L, Brown T, Brogaard Maczka A, Kapoor M, et al · · 2023 · cited 6× · PMID 36630158 · DOI 10.2196/41533
3. Dynamic Region of Interest Selection in Remote Photoplethysmography: Proof-of-Concept Study.
   Kiddle A, Barham H, Wegerif S, Petronzio C. · · 2023 · cited 2× · PMID 36995742 · DOI 10.2196/44575