Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT05889832
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2023-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Contactless Measurement of Heart Rate, Heart Rate Variability and Breathing Rate Using Remote Photoplethysmography
Sponsor:
SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: