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

NCT ID: NCT05889832

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-26
• Study Completion Date: 2023-06-06

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

HR, HRV and BR measured with Shen.AI and reference method

Group Type: EXPERIMENTAL

measurement of physiological parameters wih Shen.AI Vitals software on various camera-equipped devices (smartphones, tablets, laptops)

Intervention Type: DIAGNOSTIC_TEST

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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• age ≥ 18 years
• ability to read and write in Polish or English
• ability to operate a smartphone, tablet and laptop without the need for glasses
• ability to understand the study procedure
• ability to communicate and follow the instructions of the study staff
• written consent to participate in the study and to the processing of personal data by the research team and the sponsor of the study

Exclusion Criteria

• failure to provide the required information in the participant's information survey
• failure to comply with the study procedure or the instructions of the study stuff
• extensive facial skin damage (including abrasions, wounds, burns)
• a disease process involving a large part of the face that makes the video- based measurement impossible
• extensive face dressing
• extensive facial skin tattoo or face painting
• marked deformation of the face (e.g. a tumor)
• inability to keep the head stable in the required position during the measurement
• persistent cough making it impossible to remain still during the measurement
• respiratory dysfunction in the form of shortness of breath or irregular or shallow breathing
• diagnosed arrhythmia (except sinus bradycardia or tachycardia)
• moderate or severe anemia
• diagnosed: heart failure, left ventricular systolic dysfunction, aortic stenosis or other diseases or disorders within the heart vascular system leading to decreased stroke volume, low pressure amplitude or the so-called paradoxical pulse

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bartłomiej Paleczny

Role: PRINCIPAL_INVESTIGATOR

Wrocław Medical University

Locations

Uniwersyteckie Centrum Wsparcia Badań Klinicznych we Wrocławiu

Wroclaw, Lower Silesian Voivodeship, Poland

Countries

Poland

Other Identifiers

MDF-01-008-01

Identifier Type: -

Identifier Source: org_study_id