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Lifelight Non-Invasive Blood Pressure and Heart Rate Validation Study

NCT06535152 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-08-02

No results posted yet for this study

Summary

Lifelight is a novel, calibration-free, software-only medical device that contactlessly measures pulse rate and blood pressure by measuring remote photoplethysmography (rPPG) signals of a patient's face using a standard smartphone or tablet camera.

By conducting this validation study we aimed to demonstrate the accuracy of Lifelight for classifying the full range of clinically relevant blood pressures as hypertensive or non-hypertensive and demonstrate its accuracy for measuring pulse rate and the blood pressure of people with blood pressures relevant to Stage 1 hypertension.

Conditions

Interventions

DEVICE

Lifelight

Lifelight is a artificial-intelligence software application that enables completely contactless spot measurements (i.e., one-off measurements without prior calibration) of PR and BP. Based on the science of remote photoplethysmography (rPPG), Lifelight works by detecting tiny changes in the colour of facial skin that occur every time the heart beats. All that is required to generate PR and BP measurements is that the software application is downloaded onto a computer device (e.g., smartphone or tablet) with a standard camera, and that the patient's face stays in the line of sight of the camera for up to 60 seconds.

DEVICE

Manual sphygmomanometer

Blood Pressure Measurement

Sponsors & Collaborators

  • Element Materials Technology

    collaborator INDUSTRY

  • Mind Over Matter Medtech Ltd

    collaborator INDUSTRY

  • Xim Limited

    lead INDUSTRY

Principal Investigators

  • Arthur Cabrera, MD · Investigator has left Element Materials Technology

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-18
Primary Completion
2023-08-03
Completion
2023-08-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06535152 on ClinicalTrials.gov