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Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch (BPLONG)

Primary Purpose

Hypertension, Blood Pressure

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Long-term non-invasive Blood pressure monitoring
Sponsored by
Czech Technical University in Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension focused on measuring Smartwatch, Blood pressure, Heart rate

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy volunteer Exclusion Criteria: post-traumatic conditions of the upper limbs tattoos, birthmarks, injuries or diseases of the skin on the wrists of hands cardiac arrhythmias circulatory or peripheral varcular disease aortic valve disease myocardiopathy other cardiovascular diseases pregnancy kidney disease diabetes neurotic disorder haemostatic disorders use of blood-thinning drugs

Sites / Locations

  • Czech Technical University in Prague

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Long-term Blood pressure and Heart rate monitoring with reference digital tonometer and smartwatch

Arm Description

Measurement of a non-invasive Blood pressure and Heart rate using a reference medical grade digital tonometer Omron and a smartwatch Samsung Galaxy Watch during 20-40 days every morning and evening.

Outcomes

Primary Outcome Measures

Blood pressure agreement between smartwatch and digital tonometer
The agreement of Blood pressure measurements between smartwatch and medical grade reference digital tonometer

Secondary Outcome Measures

Heart rate agreement between smartwatch and digital tonometer
The agreement of Heart rate measurements between smartwatch and medical grade reference digital tonometer

Full Information

First Posted
October 9, 2023
Last Updated
October 18, 2023
Sponsor
Czech Technical University in Prague
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1. Study Identification

Unique Protocol Identification Number
NCT06098092
Brief Title
Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch
Acronym
BPLONG
Official Title
Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 13, 2023 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
October 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to perform an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch
Detailed Description
Blood pressure is one of the basic vital signs monitored and is one of the most important indicators of a patient's health status. Cardiovascular disease is one of the leading causes of death worldwide. One of the major risk factors for cardiovascular disease is hypertension, which is globally attributed to one third of deaths in the world population. To improve the prevention of hypertension, self-monitoring of blood pressure is increasingly recommended. This project involves an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch compared to a medical grade digital tonometer with a cuff placed on the arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Blood Pressure
Keywords
Smartwatch, Blood pressure, Heart rate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional prospective single-arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long-term Blood pressure and Heart rate monitoring with reference digital tonometer and smartwatch
Arm Type
Experimental
Arm Description
Measurement of a non-invasive Blood pressure and Heart rate using a reference medical grade digital tonometer Omron and a smartwatch Samsung Galaxy Watch during 20-40 days every morning and evening.
Intervention Type
Other
Intervention Name(s)
Long-term non-invasive Blood pressure monitoring
Other Intervention Name(s)
Long-term non-invasive Heart rate monitoring
Intervention Description
All measurements during the experiment include only non-invasive Blood pressure and Heart rate measurements. Measurements will be taken using a smartwatch attached to the wrist and a digital tonometer with a cuff placed on the other arm. Paired readings will be compared.
Primary Outcome Measure Information:
Title
Blood pressure agreement between smartwatch and digital tonometer
Description
The agreement of Blood pressure measurements between smartwatch and medical grade reference digital tonometer
Time Frame
20-40 days
Secondary Outcome Measure Information:
Title
Heart rate agreement between smartwatch and digital tonometer
Description
The agreement of Heart rate measurements between smartwatch and medical grade reference digital tonometer
Time Frame
20-40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteer Exclusion Criteria: post-traumatic conditions of the upper limbs tattoos, birthmarks, injuries or diseases of the skin on the wrists of hands cardiac arrhythmias circulatory or peripheral varcular disease aortic valve disease myocardiopathy other cardiovascular diseases pregnancy kidney disease diabetes neurotic disorder haemostatic disorders use of blood-thinning drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakub Rafl
Organizational Affiliation
Czech Technical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Czech Technical University in Prague
City
Kladno
ZIP/Postal Code
27201
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The measured data will be shared publicly in the data repository on web page: https://ventilation.fbmi.cvut.cz/data/
IPD Sharing Time Frame
Unlimited from the time of processing complete measured data
IPD Sharing Access Criteria
Publicly available to everyone
IPD Sharing URL
https://ventilation.fbmi.cvut.cz/data/

Learn more about this trial

Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch

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