NCT05401435

Brief Summary

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.

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
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

May 4, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

June 2, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

May 23, 2022

Last Update Submit

June 1, 2022

Conditions

Blood PressureHeart Rate

Keywords

blood pressure measurementheart rate measurementsmartwatch

Outcome Measures

Primary Outcomes (2)

  • Change in long-term similarity of blood pressure measurements from two devices between two consecutive calibrations

    The long-term agreement of systolic and diastolic blood pressure measurements of both monitoring devices between two consecutive smartwatch calibrations will be evaluated. This means that we evaluate the changes in the similarity of measured blood pressures over a period of 28 days.

    28 days

  • Change in long-term similarity of heart rate measurements from two devices

    The long-term agreement of heart rate measurements of both monitoring devices will be evaluated. This means that we evaluate the changes in the similarity of measured heart rates over a period of 28 days.

    28 days

Study Arms (1)

Blood pressure and heart rate measurement

EXPERIMENTAL

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.

Other: Resting measurement of blood pressure and heart rate

Interventions

Resting measurement of blood pressure and heart rateOTHER

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

Blood pressure and heart rate measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

RECRUITING

Related Publications (1)

  • van Helmond N, Freeman CG, Hahnen C, Haldar N, Hamati JN, Bard DM, Murali V, Merli GJ, Joseph JI. The accuracy of blood pressure measurement by a smartwatch and a portable health device. Hosp Pract (1995). 2019 Oct;47(4):211-215. doi: 10.1080/21548331.2019.1656991. Epub 2019 Aug 26.

    PMID: 31423912BACKGROUND

MeSH Terms

Interventions

Heart Rate

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Barbora Nezpevakova, Bc.

    Czech Technical University in Prague

    PRINCIPAL INVESTIGATOR

  • Veronika Rafl Huttova, MSc

    Czech Technical University in Prague

    PRINCIPAL INVESTIGATOR

  • Martin Rozanek, PhD

    Czech Technical University in Prague

    PRINCIPAL INVESTIGATOR

  • Jakub Rafl, PhD

    Czech Technical University in Prague

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbora Nezpevakova, Bc.

CONTACT

+420728096216nezpebar@fbmi.cvut.cz

Veronika Rafl Huttova, MSc

CONTACT

+420224355049huttover@fbmi.cvut.cz

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 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

June 2, 2022

Study Start

May 4, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

June 2, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)