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

SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce

Status

Completed

Conditions

Heart Rate Variability

Heart Rate

Blood Pressure

Breathing Rate

Treatments

Device: Shen.AI

Study type

Interventional

Funder types

Industry

Identifiers

NCT06829615

MDF-01-008-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

132 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age ≥ 18 years
Ability to read and write in Polish or English
Ability to operate a mobile device and a laptop without requiring glasses
Ability to understand the study procedure
Ability to communicate and follow instructions from the study personnel
Provision of written informed consent for participation in the study and for the processing of personal data by the research team and the study sponsor
Blood pressure values in accordance with the distribution of the study group

Exclusion criteria

Pregnancy
Age below 18 years
Failure to provide the required information in the participant's informational questionnaire
Non-compliance with the study procedure or instructions from the study personnel
Extensive facial skin damage (e.g., abrasions, wounds, burns)
A disease process affecting a significant portion of the face
Extensive facial dressing
Extensive facial tattoos or facial painting
Significant facial deformity (e.g., tumor)
Inability to maintain a stable head position during measurement
Persistent cough preventing stillness during measurement
Respiratory dysfunction such as dyspnea, irregular or shallow breathing
Diagnosed arrhythmia (except for sinus bradycardia or sinus tachycardia)
Moderate or severe anemia
Diagnosed conditions such as left ventricular systolic dysfunction, aortic valve stenosis, or other cardiac or circulatory diseases leading to low stroke volume, low pulse amplitude, or pulsus paradoxus
Implanted cardiac pacemaker
Blood pressure difference between arms exceeding 15 mmHg for systolic pressure or 10 mmHg for diastolic pressure
Inability to determine blood pressure in both arms