NCT06829615

Contactless Measurement of Heart Rate, Heart Rate Variability, Breathing Rate and Blood Pressure Using Remote Photoplethysmography

Contactless Measurement of Heart Rate, Heart Rate Variability, Breathing Rate and Blood Pressure Using Face Video Analysis (Remote Photoplethysmography) - Validation of Shen.AI Software

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study it to evaluate the accuracy of heart rate, heart rate variability, breathing rate and blood pressure measurement with the use of Shen.AI software.

Detailed description

The primary objective of this clinical study is to assess the accuracy of heart rate (HR), heart rate variability (HRV), breathing rate (BR), and blood pressure (BP) measurements obtained using Shen.AI software as the investigational device under its intended conditions of use, enabling users to obtain reliable information about their physiological state. These conditions include measurements taken at rest, in a home-like environment, with participants independently operating a mobile device or laptop equipped with a camera. Physiological parameters, including HR, HRV, BR, and BP, will be measured and estimated using remote photoplethysmography (rPPG) based on a 1-minute facial video analysis processed by Shen.AI software. Throughout all measurements, participants will be connected to a reference device that records ECG while simultaneously measuring chest impedance (impedance pneumography). Additionally, each participant will wear a respiratory belt transducer. Depending on the measurement type, the participant's blood pressure will be assessed using either an auscultatory or an automatic blood pressure monitor. The study will be conducted on a diverse group of participants, varying in blood pressure, gender, age, skin phototype, and BMI. For each measured parameter, results obtained from both methods will be compared using Bland-Altman analysis or non-parametric limits of agreement.

Conditions

• Heart Rate
• Heart Rate Variability
• Breathing Rate
• Blood Pressure

Interventions

Type	Name	Description
DEVICE	Shen.AI	Contactless measurement of heart rate, heart rate variability, breathing rate, and blood pressure using Shen.AI software and reference methods.

Timeline

• Start date: 2025-05-06
• Primary completion: 2025-10-03
• Completion: 2025-10-03
• First posted: 2025-02-17
• Last updated: 2025-11-18

Locations

2 sites across 1 country: Poland