NCT05302193

Brief Summary

The aim of this study is to verify the accuracy of blood pressure and heart rate measurement by Samsung smartwatches compared to a standard monitor of vital signs used in intensive care units.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

March 16, 2022

Last Update Submit

March 24, 2025

Conditions

Blood PressureHeart Rate

Keywords

blood pressure measurementheart rate measurementsmartwatch

Outcome Measures

Primary Outcomes (2)

  • Similarity of blood pressure measurements from two devices

    The agreement of systolic and diastolic blood pressure measurements of both monitoring devices will be evaluated.

    1 hour

  • Similarity of heart rate measurements from two devices

    The agreement of heart rate measurements of both monitoring devices will be evaluated.

    1 hour

Study Arms (1)

Blood pressure and heart rate measurement

EXPERIMENTAL

Calm measurement of blood pressure and heart rate simultaneously by smartwatch and vital signs monitor. Each participant will undergo this measurement a total of 6 times.

Other: Calm measurement of blood pressure and heart rate (before physical activity)Other: Physical activityOther: Calm measurement of blood pressure and heart rate (after physical activity)

Interventions

Calm measurement of blood pressure and heart rate (before physical activity)OTHER

Simultaneous blood pressure and heart rate measurements at minutes 2 and 5.5 of the experiment.

Blood pressure and heart rate measurement
Physical activityOTHER

Five minutes of physical activity, between times 7.5 min and 12.5 min of the experimental part. Riding on a spinning ergometer with a standardized load of 1 W/kg.

Blood pressure and heart rate measurement
Calm measurement of blood pressure and heart rate (after physical activity)OTHER

Simultaneous blood pressure and heart rate measurements at times 15.5, 17, 20.5 and 22 minutes of the experimental part.

Blood pressure and heart rate measurement

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Biomedical Engineering, Czech Technical University in Prague

Kladno, 27201, Czechia

Location

Related Publications (1)

  • Hahnen C, Freeman CG, Haldar N, Hamati JN, Bard DM, Murali V, Merli GJ, Joseph JI, van Helmond N. Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study. JMIR Mhealth Uhealth. 2020 Feb 12;8(2):e16811. doi: 10.2196/16811.

    PMID: 32049066BACKGROUND

MeSH Terms

Interventions

Heart RateExercise

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Veronika Rafl Huttova, MSc

    Czech Technical University in Prague

    PRINCIPAL INVESTIGATOR

  • Jakub Rafl, PhD

    Czech Technical University in Prague

    PRINCIPAL INVESTIGATOR

  • Martin Rozanek, PhD

    Czech Technical University in Prague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Two measuring devices are active simultaneously during measurement of blood pressure and heart rate on each participant and their functioning is compared.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2022

First Posted

March 31, 2022

Study Start

March 1, 2021

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)