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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Heart Rate Variability; Heart Rate; Breathing Rate
• Intervention / Treatment: Device: Shen.AI

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-414
      • OVO MEDICAL Sp. z o.o.
    • Wroclaw, Lower Silesian Voivodeship, Poland, 53-033
      • Przychodnia rehabilitacyjna R-MED

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HR, HRV, BR, and BP measured using Shen.AI and reference methods	Device: Shen.AI; Contactless measurement of heart rate, heart rate variability, breathing rate, and blood pressure using Shen.AI software and reference methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the average heart rate (HR) measurement using the device under test compared to the reference measurement.	Average HR will be estimated using Shen.AI software and compared with simultaneously recorded ECG .	One appointment (day 1)
Accuracy of the measurement of the heart rate variability index - Standard Deviation of Normal-to-Normal intervals (SDNN) using the device under test compared to the reference measurement.	The heart rate variability index (SDNN) will be measured using Shen.AI software and compared with the simultaneously recorded ECG.	One appointment (day 1)
Accuracy of the breathing rate (BR) measurement using the device under test compared to the reference measurement.	Average BR will be estimated using Shen.AI software and compared with the recorded impedance pneumography signal in the absence of read-out capability supported by the respiratory belt transducer.	One appointment (day 1)
Accuracy of systolic and diastolic blood pressure (BP) measurements using the device under test in relation to the reference measurement.	Average BP will be estimated using Shen.AI software and compared with auscultatory blood pressure measurements.	One appointment (day 1)
Accuracy of systolic and diastolic blood pressure (BP) measurement using the device under test, taking into account the calibration of the BP measurement function, in relation to the reference measurement.	Average BP will be estimated using Shen.AI software and compared with auscultatory blood pressure measurements. Measurements will be performed during two visits, with the second visit occurring 14 ± 3 days apart.	Two appointments (14 ± 3 days apart)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the measurement of other heart rate variability metrics - Root Mean Square of Successive Differences (RMSSD) using the device under test.	The heart rate variability index (RMSSD) will be measured using Shen.AI software and compared with the simultaneously recorded ECG.	One appointment (day 1)
Accuracy of blood oxygen saturation measurement using the device under test	The blood oxygen saturation will be measured using Shen.AI software and compared with the simultaneously obtained blood oxygen measurements.	One appointment (day 1)
Accuracy of Body Mass Index (BMI) estimation using the device under test.	The BMI will be measured using Shen.AI software and compared with the values obtained from a weight scale and stadiometer.	One appointment (day 1)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utility of the software under test for self-measurement of physiological parameters, as assessed by user and observer questionnaires.	At the end of the appointment, two questionnaires will be used to assess the usability of the Shen.AI software. User Usability Questionnaire - completed by participants to evaluate the clarity of instructions, ease of use, calibration process, interface intuitiveness, perceived safety, and overall experience. Observer Usability Questionnaire - completed by study personnel to assess patient behavior, difficulties encountered during measurements, and potential usability issues. Each questionnaire consists of multiple-choice questions (e.g., "Very intuitive", "Intuitive", "Non-intuitive", "Very unintuitive") and open-ended questions. Higher-rated responses (e.g., "Very intuitive", "Intuitive") indicate better usability and user experience, while lower-rated responses suggest usability challenges or areas for improvement. Open-ended responses will be analyzed by a dedicated research team to identify key themes, usability issues, and potential improvements.	One appointment (day 1)

Collaborators and Investigators

• Sponsor: SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce
• Investigators: Principal Investigator: Justyna Chojdak-Łukasiewicz, MD, PhD, Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Actual): October 3, 2025
• Study Completion (Actual): October 3, 2025

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: MDF-01-008-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No