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

NCT06829615 | Completed

• 1 other identifier: MDF-01-008-03
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Rate; Heart Rate Variability; Breathing Rate; Blood Pressure

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Accuracy of the measurement of other heart rate variability metrics - Root Mean Square of Successive Differences (RMSSD) using the device under test.

  One appointment (day 1)

• Accuracy of blood oxygen saturation measurement using the device under test

  One appointment (day 1)

• Accuracy of Body Mass Index (BMI) estimation using the device under test.

  One appointment (day 1)

Other Outcomes (1)

• Utility of the software under test for self-measurement of physiological parameters, as assessed by user and observer questionnaires.

  One appointment (day 1)

Study Arms (1)

HR, HRV, BR, and BP measured using Shen.AI and reference methods

EXPERIMENTAL

Device: Shen.AI

Interventions

Shen.AI DEVICE

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

HR, HRV, BR, and BP measured using Shen.AI and reference methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce: lead

Study Sites (2)

OVO MEDICAL Sp. z o.o.

Wroclaw, Lower Silesian Voivodeship, 50-414, Poland

Location

Przychodnia rehabilitacyjna R-MED

Wroclaw, Lower Silesian Voivodeship, 53-033, Poland

Location

Study Officials

• Justyna Chojdak-Łukasiewicz, MD, PhD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 17, 2025
• Study Start: May 6, 2025
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

PL (2)