Blood PressureSamsungWatchNCT04553861
Smartwatch ABPM vs. Conventional ABPM
An observational study of Blood Pressure, run by Wonju Severance Christian Hospital at 1 site in South Korea.
Trial summary
This study aims to investigate the accuracy and precision of the Samsung Smartwatch with conventional ambulatory blood pressure monitoring in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Ambulatory blood pressure monitoring and Galaxy Watch Active2
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2020to 1 Mar 2021
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects willing to participate in this trial
Who may be able to join
- Ambulatory healthy subjects
- Subjects aged 20 years or more
- Subjects willing to participate in this study voluntarily Exclusion criteria
- Subjects inability to provide informed consent
- Subjects with any medical history
- Subjects with irregular heart rhythm (e.g. atrial fibrillation, atrial flutter, or bigeminy)
- Subjects unable to wear a watch due to wrist circumference
- Subjects with BP difference 10mmHg or more between left and right arm
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
About this study
Official title: Correlation Between Smartwatch-based Blood Pressure Monitoring and Conventional Ambulatory Blood Pressure Monitoring
This study aims to investigate the accuracy and precision of the Samsung Smartwatch with conventional ambulatory blood pressure monitoring in healthy volunteers.
Read the detailed description
Blood pressure (BP) monitoring outside of the medical care environment is an increasingly important part of clinical hypertension assessment and management. Ambulatory BP monitoring (ABPM) uses automatic detection and recording devices for repeated determinations during an extended period, typically 24 hours. This technique has been shown to substantially enhance the clinician's understanding of BP behavior in patients and aid in diagnosis and therapeutic decision making. The ABPM is superior to office BP in predicting target organ, hypertensive cerebrovascular disease, retinopathy, renal abnormalities, and alterations in vascular compliance.1-4) Most of these studies have also demonstrated that a loss of nocturnal decline in BP (so-called non-dipper) conveys excessive risk for stroke and myocardial infarction.
Although conventional ABMP is usually well tolerated by patients, a few problems do exist. A minority of patients do not sleep well with the recorders and tend to have somewhat higher BP values. Cuffs can also rotate, and different arm positions can change BP significantly. Rarely, patients may develop erythema, ecchymoses, petechiae, or superficial phlebitis in the area distal to cuff placement.
Recently, smartwatches that measure BP without a cuff have become available. Since these measurements are relatively more user-friendly than conventional cuff-based measurements, they may aid in more frequent BP monitoring. Currently, only one study compared a non-commercial armband wearable pulse transit time (PTT) system for 24-hour cuff-less BP measurement with ABPM.5) We will investigate the accuracy and precision of Samsung Smartwatch with ABPM in young, healthy volunteers.
- Conditions
- Blood Pressure
- Being tested
- Ambulatory blood pressure monitoring, Galaxy Watch Active2
- Keywords
- Blood Pressure, Ambulatory blood pressure monitoring, Smartwatch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory blood pressure monitoringDevice
Every 30 minutes from 7 AM to 10 PM and every 1 hour from 10 PM to 7 AM
Galaxy Watch Active2Device
Every 1 hour by subject (on-demand) from 7 AM to 10 PM and every 5 minutes (automatic) from 10 PM to 7 AM
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Healthy subjects without blood pressure difference on both arm Receives: Device: Ambulatory blood pressure monitoring; Device: Galaxy Watch Active2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean nighttime blood pressure
Correlation of mean nighttime BP between the ABPM and the BP using the smartwatch
Measured: Baseline
Secondary outcomes (5)
Every time point blood pressure
BP differences between the ABPM and the BP using the smartwatch at every time point of measurement
Measured: Baseline
Mean 24-hour blood pressure
Correlation of mean 24-h BP between the ABPM and the BP using the smartwatch
Measured: Baseline
Mean daytime blood pressure
Correlation of mean daytime BP between the ABPM and the BP using the smartwatch
Measured: Baseline
Nighttime dipping
Correlation of nighttime dipping between the ABPM and the BP using the smartwatch
Measured: Baseline
Morning blood pressure
Correlation of morning BP between the ABPM and the BP using the smartwatch
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Principal investigator, Young Jin Youn, Wonju Severance Christian Hospital
- Investigators
- Young Jin Youn, MD, PhD, Principal investigator, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553861
- Sponsor's protocol ID
- SamsungWatch
- Acronym
- SamsungWatch
- Status last verified
- Apr 2021
- First submitted
- 11 Sep 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Smartwatch-based Blood Pressure Monitoring and Conventional Ambulatory Blood Pressure Monitoring
- ClinicalTrials.gov ID
- NCT04553861
- Acronym / sponsor ID
- SamsungWatch / SamsungWatch
- Conditions
- Blood Pressure
- Keywords
- Blood Pressure, Ambulatory blood pressure monitoring, Smartwatch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the accuracy and precision of the Samsung Smartwatch with conventional ambulatory blood pressure monitoring in healthy volunteers.
Detailed description
Blood pressure (BP) monitoring outside of the medical care environment is an increasingly important part of clinical hypertension assessment and management. Ambulatory BP monitoring (ABPM) uses automatic detection and recording devices for repeated determinations during an extended period, typically 24 hours. This technique has been shown to substantially enhance the clinician's understanding of BP behavior in patients and aid in diagnosis and therapeutic decision making. The ABPM is superior to office BP in predicting target organ, hypertensive cerebrovascular disease, retinopathy, renal abnormalities, and alterations in vascular compliance.1-4) Most of these studies have also demonstrated that a loss of nocturnal decline in BP (so-called non-dipper) conveys excessive risk for stroke and myocardial infarction.
Although conventional ABMP is usually well tolerated by patients, a few problems do exist. A minority of patients do not sleep well with the recorders and tend to have somewhat higher BP values. Cuffs can also rotate, and different arm positions can change BP significantly. Rarely, patients may develop erythema, ecchymoses, petechiae, or superficial phlebitis in the area distal to cuff placement.
Recently, smartwatches that measure BP without a cuff have become available. Since these measurements are relatively more user-friendly than conventional cuff-based measurements, they may aid in more frequent BP monitoring. Currently, only one study compared a non-commercial armband wearable pulse transit time (PTT) system for 24-hour cuff-less BP measurement with ABPM.5) We will investigate the accuracy and precision of Samsung Smartwatch with ABPM in young, healthy volunteers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Device: Ambulatory blood pressure monitoring, Device: Galaxy Watch Active2Healthy subjects without blood pressure difference on both arm |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects willing to participate in this trial
Key inclusion criteria (8 listed)
- Ambulatory healthy subjects
- Subjects aged 20 years or more
- Subjects willing to participate in this study voluntarily Exclusion criteria
- Subjects inability to provide informed consent
- Subjects with any medical history
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory blood pressure monitoringEvery 30 minutes from 7 AM to 10 PM and every 1 hour from 10 PM to 7 AM | Device | Healthy subjects |
| Galaxy Watch Active2Every 1 hour by subject (on-demand) from 7 AM to 10 PM and every 5 minutes (automatic) from 10 PM to 7 AM | Device | Healthy subjects |
Primary outcome
Mean nighttime blood pressure
Time frame: Baseline
Correlation of mean nighttime BP between the ABPM and the BP using the smartwatch
5 secondary outcomes
Every time point blood pressure
Time frame: Baseline
Mean 24-hour blood pressure
Time frame: Baseline
Mean daytime blood pressure
Time frame: Baseline
Nighttime dipping
Time frame: Baseline
Morning blood pressure
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Jin Youn, MD, PhD principal investigator
Wonju Severance Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Wonju Severance Christian Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean nighttime blood pressure (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.