NCT05117762

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

November 1, 2021

Last Update Submit

November 10, 2021

Conditions

HealthyHypertension

Keywords

PhotoplethysmographyVideo SelfieVital SignsBlood PressureOxygen SaturationSmartphoneDocMeHeart RateRespiratory Rate

Outcome Measures

Primary Outcomes (4)

  • Heart Rate

    Heart Rate (beats/minute) assessed 3 times at 10 minute intervals on one occasion

    Baseline

  • 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

  • Heart Rate Variability

    Heart Rate (beats/minute) 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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford University Hospitals NHS Foundation

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related 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.

    PMID: 31599362BACKGROUND

  • 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.

    PMID: 31382766BACKGROUND

  • 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.

    PMID: 32492902BACKGROUND

  • 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.

    PMID: 17477684BACKGROUND

  • 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.

    PMID: 23938616BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Alex T Novak, MRCGP FRCEM

    Oxford University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2021

First Posted

November 11, 2021

Study Start

November 2, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

November 11, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)