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Lifelight and BP measurement for High Blood Pressure

N/A

Waitlist Available

Led By Arthur Cabrera, MD

Research Sponsored by Xim Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Healthy volunteers aged 18 to 85 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

High Blood Pressure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood Pressure Classification Accuracy

Blood Pressure Measurement Accuracy (relevant to Stage 1 hypertension

Pulse Rate Measurement Accuracy (relevant to Stage 1 hypertension

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lifelight and BP measurementExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lifelight

2023

N/A

~90

Manual sphygmomanometer

2023

N/A

~90