Validation Study of Selfie Technology for Assessment of Vital Signs

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart Rate (beats/minute) assessed 3 times at 10 minute intervals on one occasion | Baseline | 
| 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 | 
| Heart Rate Variability | HRV (ms) assessed 3 times at 10 minute intervals on one occasion | Baseline | 
| Blood Pressure | Systolic and Diastolic Blood Pressure assessed 3 times at 10 minute intervals on one occasion | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photoplethysmography, Video Selfie, Vital Signs, Blood Pressure, Smartphone, DocMe, Heart Rate, Respiratory Rate