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

NCT05889832 | Completed

• 1 other identifier: MDF-01-008-01
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Rate; Heart Rate Variability; Respiratory Rate

Outcome Measures

Primary Outcomes (4)

• Accuracy of heart rate (HR) measurement with the software under test compared with the ECG-based measurement

  In each participant, average HR will be estimated from 1-minute video-based remote photoplethysmography of the facial skin (software under test) and calculated from simultaneously recorded ECG. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device. The results from both methods will be compared using non-parametric limits of agreement.

  day 1 (single visit, approximately 30 minutes)

• Accuracy of heart rate variability index (SDNN) measurement with the software under test compared with the ECG-based measurement

  In each participant, the standard deviation of normal heartbeat intervals (SDNN) will be estimated from 1-minute video-based remote photoplethysmography of the facial skin (software under test) and calculated from simultaneously recorded ECG. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device. The results from both methods will be compared using the Bland-Altman analysis.

  day 1 (single visit, approximately 30 minutes)

• Accuracy of breathing rate (BR) measurement with the software under test compared with the impedance pneumography-based measurement

  In each participant, the breathing rate will be estimated from 1-minute video-based remote photoplethysmography of the facial skin (software under test) and calculated from simultaneously recorded impedance pneumography signal. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device. The results from both methods will be compared using the Bland-Altman analysis.

  day 1 (single visit, approximately 30 minutes)

• Accuracy of instantaneous heart rate measurement with the software under test compared with the ECG-based measurement

  In each participant, multiple instantaneous heart rate values (averaged over 10 s) will be estimated from the software under test and calculated from simultaneously recorded ECG. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device. The results from both methods will be compared using non-parametric limits of agreement.

  day 1 (single visit, approximately 30 minutes)

Secondary Outcomes (14)

• Accuracy of measurement of heart rate (HR) with the software under test on a smartphone held by someone else (compared with reference measurements).

  day 1 (single visit, approximately 30 minutes)

• 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).

  day 1 (single visit, approximately 30 minutes)

• Accuracy of measurement of breathing rate (BR) with the software under test on a smartphone held by someone else (compared with reference measurements).

  day 1 (single visit, approximately 30 minutes)

• Accuracy of measurement of heart rate (HR) with the software under test on a smartphone held in hand/s (compared with reference measurements).

  day 1 (single visit, approximately 30 minutes)

• 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).

  day 1 (single visit, approximately 30 minutes)

Study Arms (1)

HR, HRV and BR measured with Shen.AI and reference method

EXPERIMENTAL

Diagnostic Test: measurement of physiological parameters wih Shen.AI Vitals software on various camera-equipped devices (smartphones, tablets, laptops)

Interventions

measurement of physiological parameters wih Shen.AI Vitals software on various camera-equipped devices (smartphones, tablets, laptops) DIAGNOSTIC_TEST

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). Reference measurements will be taken simultaneously (chest ECG for the calculation of HR and HRV; impedance pneumography for BR).

HR, HRV and BR measured with Shen.AI and reference method

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Uniwersyteckie Centrum Wsparcia Badań Klinicznych we Wrocławiu

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

Study Officials

• Bartłomiej Paleczny

  Wrocław 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: April 17, 2023
• First Posted: June 5, 2023
• Study Start: April 26, 2023
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: March 28, 2024

Record last verified: 2023-06

Locations

PL (1)