Clinical trial NCT04688112: Validation Study of Selfie Technology for Assessment of Vital Signs
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Healthy
Keywords: Photoplethysmography
Video Selfie
Vital Signs
Blood Pressure
Smartphone
DocMe
Heart Rate
Respiratory Rate
Lead sponsor: DocMe Technologies Ltd
Sponsor class: INDUSTRY
Collaborators: name: Oxford University Hospitals NHS Trust
First posted: 2020-12-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will seek to adhere to ISO (81060-2:2018)guidelines and AHA BP consensus standards.

* at least 5% population reference range systolic BP \<100mmHg
* at least 5% population reference range systolic BP \>160mmHg
* at least 20% population reference range systolic BP \>140mmHg
* at least 5% population reference range diastolic BP \<60mmHg
* at least 5% population reference range diastolic BP \>100mmHg
* at least 20% population reference range diastolic BP \>80mmHg

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Heart Rate
timeFrame: Baseline
measure: Respiratory Rate
timeFrame: Baseline
measure: Heart Rate Variability
timeFrame: Baseline
measure: Blood Pressure
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Alex T Novak, MRCGP FRCEM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.