Lifelight Non-Invasive Blood Pressure and Heart Rate Validation Study

CLINIMARK Clinical Investigation Plan Lifelight Non-Invasive Blood Pressure Validation Study PR 2021-443

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Lifelight; Device: Manual sphygmomanometer

Detailed Description

Lifelight was investigated in a study that followed the data collection and data analysis methodology outlined in ISO 81060-2:2018/AMD 1:2020 "Non-invasive Sphygmomanometers - Part 2: Clinical investigation of automated measurement type". This validation study was conducted by independent laboratory Element Materials Technology Boulder (formerly Clinimark), a global leader for clinical testing of vital sign data for medical devices and consumer wearable products. The study generated data from 85 people aged 18-85 with the wide-ranging distribution of blood pressures specified in ISO 81060-2:2018/AMD 1:2020.The accuracy of Lifelight's blood pressure measurements was assessed by comparing Lifelight's measurements with measurements made by dual-observer manual auscultation using the same-arm sequential method specified in ISO 81060-2:2018/AMD 1:2020. The accuracy of Lifelight's pulse rate measurements was assessed by comparing Lifelight's measurements with concurrent ECG-derived heart rate values. Data was collected in an Independent Review Board-approved study conducted by independent laboratory Clinimark (now Element) in the USA and repurposed for the testing of the new improved model in the latest version of the Lifelight® EA device. The data collected consists of 85 participants, with three readings each. The participants were resting before their measurements were taken to ensure stable blood pressure. For each Lifelight measurement, two sets of blood pressure measurements were taken using dual-observer manual auscultation. The first measurement was taken before the Lifelight measurement and the second just after. If there was too much variation between the before and after measurement, or between the two independent observers, the measurement was discarded and repeated. For this validation procedure, the measurements taken during the original study were re-processed in the new updated algorithm.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Element Materials Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy volunteers aged 18 to 85 years old

Exclusion Criteria:

• Participants were excluded from the study if they were medically unsuitable for participation at time of visit, any heart dysrhythmias (except respiratory sinus arrhythmia) as confirmed with a 3 lead ECG, compromised circulation or peripheral vascular disease, clotting disorders, female participants who were pregnant or trying to get pregnant, excessive facial hair, and conditions that affect the skin, such as anaemia, jaundice, rosacea, psoriasis, acute acne, and erythropoietic protoporphyria.

Participants could choose to withdraw themselves from the study without prejudice or they could be withdrawn by study investigators for predetermined reasons. Data excluded from the analysis was documented with justifications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lifelight and BP measurement; The accuracy of Lifelight's blood pressure measurements was assessed by comparing Lifelight's measurements with measurements made by dual-observer manual auscultation using the same-arm sequential method specified in ISO 81060-2:2018/AMD 1:2020. The accuracy of Lifelight's pulse rate measurements was assessed by comparing Lifelight's measurements with concurrent ECG-derived heart rate values. The participants were resting before their measurements were taken to ensure stable blood pressure. For each Lifelight measurement, two sets of blood pressure measurements were taken using dual-observer manual auscultation. The first measurement was taken before the Lifelight measurement and the second just after. If there was too much variation between the before and after measurement, or between the 2 independent observers, the measurement was discarded and repeated. For this validation procedure, the measurements taken during the original study were re-processed in the new updated algorithm.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Classification Accuracy	Demonstrate the accuracy of Lifelight for classifying the full range of clinically relevant blood pressures as hypertensive or non-hypertensive.	Up to 3 Months
Pulse Rate Measurement Accuracy (relevant to Stage 1 hypertension	Demonstrate its accuracy for measuring pulse rate (bpm)	Up to 3 Months
Blood Pressure Measurement Accuracy (relevant to Stage 1 hypertension	the blood pressure (mmHg) of people with blood pressures relevant to Stage 1 hypertension	Up to 3 Months

Collaborators and Investigators

• Sponsor: Xim Limited
• Collaborators: Mind Over Matter Medtech Ltd; Element Materials Technology
• Investigators: Principal Investigator: Arthur Cabrera, MD, Investigator has left Element Materials Technology

Publications and helpful links

Helpful Links

• Contactless and Calibration-free Blood Pressure and Pulse Rate Monitor for Screening and Monitoring of Hypertension: Cross-sectional Validation Study

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Actual): August 3, 2023
• Study Completion (Actual): August 3, 2023

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: PR 2021-443

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No