Heart Rate Variability Clinical Trial
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.
Verified date | June 2023 |
Source | MX LABS spólka z ograniczona odpowiedzialnoscia oddzial w Polsce |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 136 |
Est. completion date | June 6, 2023 |
Est. primary completion date | June 6, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Uniwersyteckie Centrum Wsparcia Badan Klinicznych we Wroclawiu | Wroclaw | Dolnoslaskie |
Lead Sponsor | Collaborator |
---|---|
MX LABS spólka z ograniczona odpowiedzialnoscia oddzial w Polsce |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Accuracy of measurement of heart rate (HR) with the software under test on a smartphone held by someone else (compared with reference measurements). | Each participant will have one video-based measurement performed with the software under test on a smartphone held by someone else (facial video measurement of HR using the rear camera).
For reference, HR will be calculated from the simultaneously recorded ECG signal. The results from both methods will be compared using non-parametric limits of agreement. |
day 1 (single visit, approximately 30 minutes) | |
Secondary | 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). | Each participant will have one video-based measurement performed with the software under test on a smartphone held by someone else (facial video measurement of SDNN using the rear camera).
For reference, SDNN will be calculated from the simultaneously recorded ECG signal. The results from both methods will be compared using the Bland-Altman analysis. |
day 1 (single visit, approximately 30 minutes) | |
Secondary | Accuracy of measurement of breathing rate (BR) with the software under test on a smartphone held by someone else (compared with reference measurements). | Each participant will have one video-based measurement performed with the software under test on a smartphone held by someone else (facial video measurement of BR using the rear camera).
For reference, BR will be obtained from the simultaneously recorded impedance pneumography signal. The results from both methods will be compared using the Bland-Altman analysis. |
day 1 (single visit, approximately 30 minutes) | |
Secondary | Accuracy of measurement of heart rate (HR) with the software under test on a smartphone held in hand/s (compared with reference measurements). | Each participant will have one video measurement performed with the software under test on a smartphone held in hand/s (facial video measurement of HR using the rear camera).
For reference, HR will be calculated from the simultaneously recorded ECG signal. The results from both methods will be compared using non-parametric limits of agreement. |
day 1 (single visit, approximately 30 minutes) | |
Secondary | 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). | Each participant will have one video measurement performed with the software under test on a smartphone held in hand/s (facial video measurement of SDNN using the rear camera).
For reference, SDNN will be calculated from the simultaneously recorded ECG signal. The results from both methods will be compared using the Bland-Altman analysis. |
day 1 (single visit, approximately 30 minutes) | |
Secondary | Accuracy of measurement of breathing rate (BR) with the software under test on a smartphone held in hand/s (compared with reference measurements). | Each participant will have one video measurement performed with the software under test on a smartphone held in hand/s (facial video measurement of BR using the rear camera).
For reference, BR will be obtained from the simultaneously recorded impedance pneumography signal. The results from both methods will be compared using the Bland-Altman analysis. |
day 1 (single visit, approximately 30 minutes) | |
Secondary | Accuracy of measurement of heart rate (HR) with the software under test in daylight conditions (compared with reference measurements). | Each participant will have one facial video measurement performed in daylight conditions (1-minute measurement of HR using the front smartphone camera).
For reference, HR will be calculated from the simultaneously recorded ECG signal. The results from both methods will be compared using non-parametric limits of agreement. |
day 1 (single visit, approximately 30 minutes) | |
Secondary | 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). | Each participant will have one facial video measurement performed in daylight conditions (1-minute measurement of SDNN using the front smartphone camera).
For reference, SDNN will be calculated from the simultaneously recorded ECG signal. The results from both methods will be compared using the Bland-Altman analysis. |
day 1 (single visit, approximately 30 minutes) | |
Secondary | Accuracy of measurement of breathing rate (BR) with the software under test in daylight conditions (compared with reference measurements). | Each participant will have one facial video measurement performed in daylight conditions (1-minute measurement of BR using the front smartphone camera).
For reference, BR will be obtained from the simultaneously recorded impedance pneumography signal. The results from both methods will be compared using the Bland-Altman analysis. |
day 1 (single visit, approximately 30 minutes) | |
Secondary | Accuracy of measurement of heart rate (HR) with the software under test in the supine position (compared with reference measurements). | Each participant will have one facial video measurement performed in the supine position (1-minute measurement of HR using the front smartphone camera).
For reference, HR will be calculated from the simultaneously recorded ECG signal. The results from both methods will be compared using non-parametric limits of agreement. |
day 1 (single visit, approximately 30 minutes) | |
Secondary | 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). | Each participant will have one facial video measurement performed in the supine position (1-minute measurement of SDNN using the front smartphone camera).
For reference, SDNN will be calculated from the simultaneously recorded ECG signal. The results from both methods will be compared using the Bland-Altman analysis. |
day 1 (single visit, approximately 30 minutes) | |
Secondary | Accuracy of measurement breathing rate (BR) with the software under test in the supine position (compared with reference measurements). | Each participant will have one facial video measurement performed in the supine position (1-minute measurement of BR using the front smartphone camera).
For reference BR will be obtained from the simultaneously recorded impedance pneumography signal. The results from both methods will be compared using the Bland-Altman analysis. |
day 1 (single visit, approximately 30 minutes) | |
Secondary | Utility of the software under test for self-measurement of physiological parameters (assessed with a questionnaire). | The utility of the software under test for self-measurement of physiological parameters (HR, SDNN, and BR) will be assessed based on of the average score in the participant's questionnaire completed by each participant after the test procedure (i.e. after all measurements in the given participant).
The scale will be 1-5, with higher scores meaning better outcome. |
day 1 (after a single visit, approximately 30 minutes) | |
Secondary | Utility of the software under test for the measurement of someone's physiological parameters (assessed with a questionnaire). | The utility of the software under test for the video-based measurement of someone's physiological parameters will be assessed based on the average score in the participant's questionnaire (the part of the questionnaire related to the measurement with the rear camera of a smartphone) completed by each participant after the test procedure(i.e. after all measurements in the given participant).
The scale will be 1-5, with higher scores meaning better outcome. |
day 1 (after a single visit, approximately 30 minutes) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Recruiting |
NCT04554160 -
Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
|
||
Completed |
NCT02153385 -
Effects of Yoga on Heart Rate Variability and Mood in Women
|
N/A | |
Terminated |
NCT04381182 -
Heart Rate Variability and Stress Management Enhancement
|
N/A | |
Active, not recruiting |
NCT04342078 -
Vitamin D and Health Outcomes in Preterm Born Population
|
||
Completed |
NCT03068182 -
Effects of Arm Crank Versus Treadmill Exercises on Heart Rate Variability in Adult Subjects.
|
N/A | |
Recruiting |
NCT06101225 -
Effects of a Relaxation and Guided Imagery Intervention in School Context
|
N/A | |
Recruiting |
NCT05679882 -
Effects of Natural Sounds on Attention Restoration Outdoors
|
N/A | |
Recruiting |
NCT05950698 -
Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.
|
||
Completed |
NCT05093439 -
Heart Rate Variability at the Emergency Department
|
||
Completed |
NCT04487899 -
Analysis of Heart Rate Variability During Emergency Flight Simulator Missions in Fighter Pilots
|
||
Recruiting |
NCT05560893 -
The Heart of the Community Study
|
N/A | |
Completed |
NCT04869176 -
Effect of Caffeine on Heart Rate Variability in Newborns
|
N/A | |
Recruiting |
NCT06425939 -
Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Exercise Performance
|
N/A | |
Recruiting |
NCT05869721 -
Effects of Yoga on Women With Breast Cancer
|
N/A | |
Recruiting |
NCT06450483 -
Compare the Effects of Different AVNS Parameters on Neck Pain, HRV, Balance in Collegiate Atheletes
|
N/A | |
Completed |
NCT02137057 -
The Effect of Spinal Anesthesia on Heart Rate Variability in Diabetic Patients
|
N/A | |
Completed |
NCT01908920 -
Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects
|
N/A | |
Not yet recruiting |
NCT05296616 -
Sleep Quality, Stress Level and Heart Rate Variability of University Students
|
N/A | |
Recruiting |
NCT04826601 -
The Physical and Psychologic Effects of Aromatherapy in Cancer Patients During Chemotherapy
|
N/A |