Reliability of Measuring Blood Pressure With a Smartwatch

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-04

Study Completion Date

2022-09-30

Brief Summary

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The aim of this study is to verify the long-term accuracy of blood pressure and heart rate measurements by Samsung smartwatches between two consecutive calibrations compared to a standard digital tonometer used in clinical practice and for home measurement of these vital parameters.

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Detailed Description

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Recently, smartwatches can measure a wide range of biological signals, including heart rate and blood pressure. The short-term reliability of blood pressure measurements after the required calibration has been studied, but long-term reliability is still a question. The aim of the project is to experimentally evaluate the reliability of long-term blood pressure measurement with a Samsung smart watch between two consecutive calibrations over a period of 28 days in comparison with a digital tonometer (Omron) approved as a medical device. Volunteers will measure blood pressure and heart rate manually twice a day from a smartwatch and a digital tonometer simultaneously. The agreement of the measurements of both devices will be evaluated.

Conditions

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Blood Pressure Heart Rate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Two measuring devices are active simultaneously during single measurement of blood pressure and heart rate on each participant. Measurements are repeated 2 times a day for 28 days. The functioning of two measuring devices is compared.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Blood pressure and heart rate measurement

Resting blood pressure and heart rate measurement regularly one value in the morning and evening for 28 days. The volunteer measures the parameters simultaneously on both devices (smartwatch and digital tonometer). In total, each participant will undergo this measurement 56 times.

Group Type EXPERIMENTAL

Resting measurement of blood pressure and heart rate

Intervention Type OTHER

Simultaneous blood pressure and heart rate measurement every morning and evening during the duration of the experiment (28 days).

Interventions

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Resting measurement of blood pressure and heart rate

Simultaneous blood pressure and heart rate measurement every morning and evening during the duration of the experiment (28 days).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers

Exclusion Criteria

* any acute illness
* pregnancy
* severe cardiovascular conditions
* severe asthma or other severe respiratory conditions
* diabetes
* hypotension or hypertension

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes