NCT05889832

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (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 and breathing rate measurement with the use of Shen.AI Vitals software developed by MX Labs.

Detailed description

Resting heart rate (HR), heart rate variability (HRV) and breathing rate (BR) will be measured (estimated) with the use of remote photoplethysmography (1-minute face video analysis with Shen.AI Vitals software). The measurements will be taken with various camera-equipped devices (smartphones, tablets, laptops) using either front camera (self-measurement) or rear camera (measurement made by someone else), in two different lighting conditions (artificial light or natural daylight), with various levels of device stability (fully stable or held in hand/s), and in two different body positions (sitting or supine). In total, each participant will have 8 measurements taken. Standard deviation of normal heartbeat intervals (SDNN) will be used as the main HRV index. Apart from the average HR (averaged over the whole 1-minute measurement), instantaneous values of HR (averaged over 10 s) will also be determined and displayed every 1 s by the Shen.AI VItals software. In all cases, reference measurements will be taken simultaneously (chest ECG for the calculation of average and instantaneous HR as well as HRV; impedance pneumography for the determination of BR). The reference measurements will be taken with Finapres Nova with the ECG+Resp module (Finapres Medical Systems B.V.). For each measured parameter, the results from both methods will be compared using the Bland-Altman analysis or non-parametric limits of agreement.

Conditions

• Heart Rate
• Heart Rate Variability
• Respiratory Rate

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	measurement of physiological parameters wih Shen.AI Vitals software on various camera-equipped devices (smartphones, tablets, laptops)	Resting heart rate (HR), heart rate variability (HRV) and breathing rate (BR) will be measured (estimated) with the use of remote photoplethysmography (1-minute face video analysis with Shen.AI Vitals software). Reference measurements will be taken simultaneously (chest ECG for the calculation of HR and HRV; impedance pneumography for BR).

Timeline

• Start date: 2023-04-26
• Primary completion: 2023-06-06
• Completion: 2023-06-06
• First posted: 2023-06-05
• Last updated: 2024-03-28

Locations

1 site across 1 country: Poland