Measuring heart rate and blood pressure using a mobile device camera
Contactless Measurement of Heart Rate, Heart Rate Variability, Breathing Rate and Blood Pressure Using Face Video Analysis (Remote Photoplethysmography) - Validation of Shen.AI Software
This study is testing if a mobile app can accurately measure heart rate, breathing rate, and blood pressure just by recording a short video of your face.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce Industry-sponsored |
| Locations | 2 sites (Wrocław, Dolnośląskie and 1 other locations) |
| Trial ID | NCT06829615 on ClinicalTrials.gov |
What this trial studies
This study evaluates the accuracy of heart rate, heart rate variability, breathing rate, and blood pressure measurements using Shen.AI software. Participants will independently operate a mobile device or laptop equipped with a camera to capture a one-minute facial video, which will be analyzed using remote photoplethysmography. Measurements will be compared against reference devices that record ECG and chest impedance, ensuring a comprehensive assessment of the software's reliability in a home-like environment. The study aims to include a diverse group of participants to enhance the generalizability of the findings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who can operate a mobile device or laptop and communicate effectively in Polish or English.
Not a fit: Patients with significant facial deformities, extensive facial skin damage, or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide patients with a convenient and accurate method to monitor their cardiovascular health remotely.
How similar studies have performed: While the use of remote photoplethysmography is a growing field, this specific application with Shen.AI software is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wrocław, Dolnośląskie and 1 other locations
- OVO MEDICAL Sp. z o.o. — Wrocław, Dolnośląskie, Poland (Not_yet_recruiting)
- Przychodnia rehabilitacyjna R-MED — Wrocław, Dolnośląskie, Poland (Recruiting)
Study contacts
- Principal investigator: Justyna Chojdak-Łukasiewicz, MD, PhD — Wroclaw Medical University
- Study coordinator: Przemysław Jaworski
- Email: pjaworski@mxlabs.ai
- Phone: +48691033779
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.