Lifelight Non-Invasive Blood Pressure and Heart Rate Validation Study

NCT06535152 | Completed

• 1 other identifier: PR 2021-443
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Lifelight and BP measurement

EXPERIMENTAL

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; Device: Manual sphygmomanometer

Interventions

Lifelight DEVICE

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.

Lifelight and BP measurement

Manual sphygmomanometer DEVICE

Blood Pressure Measurement

Lifelight and BP measurement

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers aged 18 to 85 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xim Limited: lead
• Element Materials Technology: collaborator
• Mind Over Matter Medtech Ltd: collaborator

Study Sites (1)

Element Materials Technology

Louisville, Colorado, 80027, United States

Location

Related Links

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

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arthur Cabrera, MD

  Investigator has left Element Materials Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Up to eight pairs of reference and Lifelight recordings (starting and ending with reference recordings) were taken sequentially to obtain a minimum of three valid paired reference and Lifelight BP measurements. At least 60 seconds elapsed between each BP determination.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 2, 2024
• Study Start: May 18, 2023
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)