NCT04688112

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 Mar 2022

Typical duration 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

December 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 28, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

2.5 years

First QC Date

December 23, 2020

Last Update Submit

September 5, 2023

Conditions

Healthy

Keywords

PhotoplethysmographyVideo SelfieVital SignsBlood PressureSmartphoneDocMeHeart 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 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

Eligibility Criteria

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

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

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

December 23, 2020

First Posted

December 29, 2020

Study Start

March 28, 2022

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)