A Validation Study of Selfie Technology for Assessment of Vital Signs

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05117762

Enrollment

300

Registered

2021-11-11

Start date

2021-11-02

Completion date

2022-03-31

Last updated

2021-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Hypertension

Keywords

Photoplethysmography, Video Selfie, Vital Signs, Blood Pressure, Oxygen Saturation, Smartphone, DocMe, Heart Rate, Respiratory Rate

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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results