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NCT04688112 Clinical Trial

Validation Study of Selfie Technology for Assessment of Vital Signs

Healthy Clinical Trial

Official title:
A Validation Study Comparing the Heart Rate, Respiratory Rate, Heart Rate Variability and Blood Pressure Obtained by Video Selfie Using the DocMe® Technology With Those Obtained by Direct Measurement in Healthy People

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04688112
Other study ID # PRFX-2020-01-DocMe
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 28, 2022
Est. completion date September 30, 2024

Study information
Verified date September 2023
Source DocMe Technologies Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to compare accuracy of DocMe, a video technology developed by DocMe Health Technologies, with previously validated medical devices used for measurements of heart rate, heart rate variability, respiratory rate and blood pressure in adults.

Description:

Photoplethysmography (PPG) makes uses of low-intensity infrared (IR) light. When light travels through biological tissues, it is absorbed by bones, skin pigments and both venous and arterial blood. However, as light is more strongly absorbed by blood than the surrounding tissues, the changes in blood flow can be detected by PPG sensors as changes in the intensity of light. The signal from PPG is proportional to the quantity of blood flowing through the blood vessels and even small changes in blood volume can be detected using this method. Analysis of the waveform can provide information on a range of physiological measurements affecting the cardiovascular and respiratory systems. PPG is widely used in medicine in the form of pulse oximeters using sensors applied to peripheral digits. Recently, it has been shown that PPG data can be obtained using images acquired from videos taken using the camera on smartphones and there is now a significant and growing body of published literature to support this. DocMe Health Technologies has developed a system of obtaining these data using a 15 second video selfie. At this time, the technology has been shown to be reasonably accurate when compared to home devices in healthy subjects. However, to make the technology more widely useful, the results obtained by video selfies need to be formally validated. The aim of the study therefore is to compare measurements obtained from video selfies with measurements taken using already validated machines in the same patients.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 300
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Adults (18 - 90 years old). - Participants must be willing and able to give informed consent for participation in the study, and considered fit for the study by the nurse.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Oxford University Hospitals NHS Foundation Trust Oxford Oxfordshire

Sponsors (2)
Lead Sponsor Collaborator
DocMe Technologies Ltd Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

Barszczyk A, Lee K. Measuring Blood Pressure: from Cuff to Smartphone. Curr Hypertens Rep. 2019 Oct 10;21(11):84. doi: 10.1007/s11906-019-0990-3. — View Citation

Chowdhury MH, Shuzan MNI, Chowdhury MEH, Mahbub ZB, Uddin MM, Khandakar A, Reaz MBI. Estimating Blood Pressure from the Photoplethysmogram Signal and Demographic Features Using Machine Learning Techniques. Sensors (Basel). 2020 Jun 1;20(11):3127. doi: 10.3390/s20113127. — View Citation

Humphreys K, Ward T, Markham C. Noncontact simultaneous dual wavelength photoplethysmography: a further step toward noncontact pulse oximetry. Rev Sci Instrum. 2007 Apr;78(4):044304. doi: 10.1063/1.2724789. — View Citation

Kong L, Zhao Y, Dong L, Jian Y, Jin X, Li B, Feng Y, Liu M, Liu X, Wu H. Non-contact detection of oxygen saturation based on visible light imaging device using ambient light. Opt Express. 2013 Jul 29;21(15):17464-71. doi: 10.1364/OE.21.017464. — View Citation

Luo H, Yang D, Barszczyk A, Vempala N, Wei J, Wu SJ, Zheng PP, Fu G, Lee K, Feng ZP. Smartphone-Based Blood Pressure Measurement Using Transdermal Optical Imaging Technology. Circ Cardiovasc Imaging. 2019 Aug;12(8):e008857. doi: 10.1161/CIRCIMAGING.119.008857. Epub 2019 Aug 6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Heart Rate Heart Rate (beats/minute) assessed 3 times at 10 minute intervals on one occasion Baseline
Primary Respiratory Rate Respiratory Rate in respirations/min assessed visually or oximeter if it has the capability assessed 3 times at 10 minute intervals on one occasion Baseline
Primary Heart Rate Variability HRV (ms) assessed 3 times at 10 minute intervals on one occasion Baseline
Primary Blood Pressure Systolic and Diastolic Blood Pressure assessed 3 times at 10 minute intervals on one occasion Baseline
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