Clinical trial NCT06829615: Contactless Measurement of Heart Rate, Heart Rate Variability, Breathing Rate and Blood Pressure Using Remote Photoplethysmography
Official title: Contactless Measurement of Heart Rate, Heart Rate Variability, Breathing Rate and Blood Pressure Using Face Video Analysis (Remote Photoplethysmography) - Validation of Shen.AI Software
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Rate
Heart Rate Variability
Breathing Rate
Blood Pressure
Lead sponsor: SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of the average heart rate (HR) measurement using the device under test compared to the reference measurement.
timeFrame: One appointment (day 1)
measure: 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.
timeFrame: One appointment (day 1)
measure: Accuracy of the breathing rate (BR) measurement using the device under test compared to the reference measurement.
timeFrame: One appointment (day 1)
measure: Accuracy of systolic and diastolic blood pressure (BP) measurements using the device under test in relation to the reference measurement.
timeFrame: One appointment (day 1)
measure: 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.
timeFrame: Two appointments (14 ± 3 days apart)
Secondary outcomes:
measure: Accuracy of the measurement of other heart rate variability metrics - Root Mean Square of Successive Differences (RMSSD) using the device under test.
timeFrame: One appointment (day 1)
measure: Accuracy of blood oxygen saturation measurement using the device under test
timeFrame: One appointment (day 1)
measure: Accuracy of Body Mass Index (BMI) estimation using the device under test.
timeFrame: One appointment (day 1)
Other outcomes:
measure: Utility of the software under test for self-measurement of physiological parameters, as assessed by user and observer questionnaires.
timeFrame: One appointment (day 1)
Locations:
city: Wrocław
country: Poland
facility: OVO MEDICAL Sp. z o.o.
state: Dolnośląskie
city: Wrocław
country: Poland
facility: Przychodnia rehabilitacyjna R-MED
state: Dolnośląskie
Study officials:
affiliation: Wroclaw Medical University
name: Justyna Chojdak-Łukasiewicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: