A 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 DocMe® Technology With Those Obtained by Direct Measurement in Adults

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05117762
• Other study ID #: PRFX-2020-01
• Status: Enrolling by invitation
• Start date: November 2, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: November 2021
• Source: DocMe Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• 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 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: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adults (18 - 100 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.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Healthy
• Hypertension

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Foundation	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. Review. — 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). pii: E3127. 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. — 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 breaths/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	Heart Rate (beats/minute) 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