Clinical trial NCT05889832: Contactless Measurement of Heart Rate, Heart Rate Variability and Breathing Rate Using Remote Photoplethysmography
Official title: Contactless Measurement of Heart Rate, Heart Rate Variability and Breathing Rate Using Face Video Analysis (Remote Photoplethysmography) - Validation of Shen.AI Vitals Software.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Rate
Heart Rate Variability
Respiratory Rate
Lead sponsor: SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 136
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 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.

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

Primary outcomes:
measure: Accuracy of heart rate (HR) measurement with the software under test compared with the ECG-based measurement
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of heart rate variability index (SDNN) measurement with the software under test compared with the ECG-based measurement
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of breathing rate (BR) measurement with the software under test compared with the impedance pneumography-based measurement
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of instantaneous heart rate measurement with the software under test compared with the ECG-based measurement
timeFrame: day 1 (single visit, approximately 30 minutes)
Secondary outcomes:
measure: Accuracy of measurement of heart rate (HR) with the software under test on a smartphone held by someone else (compared with reference measurements).
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test on a smartphone held by someone else (compared with reference measurements).
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of measurement of breathing rate (BR) with the software under test on a smartphone held by someone else (compared with reference measurements).
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of measurement of heart rate (HR) with the software under test on a smartphone held in hand/s (compared with reference measurements).
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test on a smartphone held in hand/s (compared with reference measurements).
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of measurement of breathing rate (BR) with the software under test on a smartphone held in hand/s (compared with reference measurements).
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of measurement of heart rate (HR) with the software under test in daylight conditions (compared with reference measurements).
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test in daylight conditions (compared with reference measurements).
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of measurement of breathing rate (BR) with the software under test in daylight conditions (compared with reference measurements).
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of measurement of heart rate (HR) with the software under test in the supine position (compared with reference measurements).
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test in the supine position (compared with reference measurements).
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Accuracy of measurement breathing rate (BR) with the software under test in the supine position (compared with reference measurements).
timeFrame: day 1 (single visit, approximately 30 minutes)
measure: Utility of the software under test for self-measurement of physiological parameters (assessed with a questionnaire).
timeFrame: day 1 (after a single visit, approximately 30 minutes)
measure: Utility of the software under test for the measurement of someone's physiological parameters (assessed with a questionnaire).
timeFrame: day 1 (after a single visit, approximately 30 minutes)
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Uniwersyteckie Centrum Wsparcia Badań Klinicznych we Wrocławiu
state: Dolnośląskie
Study officials:
affiliation: Wrocław Medical University
name: Bartłomiej Paleczny
role: PRINCIPAL_INVESTIGATOR
References: