Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
NCT Number: NCT04553861
This study aims to investigate the accuracy and precision of the Samsung Smartwatch with conventional ambulatory blood pressure monitoring in healthy volunteers.
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Notify Me20 year and older
All sexes
Observational
Wŏnju, Gangwon-do, 26426, South Korea
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Every 30 minutes from 7 AM to 10 PM and every 1 hour from 10 PM to 7 AM
Every 1 hour by subject (on-demand) from 7 AM to 10 PM and every 5 minutes (automatic) from 10 PM to 7 AM
Time frame: Baseline
Correlation of mean nighttime BP between the ABPM and the BP using the smartwatch
Time frame: Baseline
BP differences between the ABPM and the BP using the smartwatch at every time point of measurement
Time frame: Baseline
Correlation of mean 24-h BP between the ABPM and the BP using the smartwatch
Time frame: Baseline
Correlation of mean daytime BP between the ABPM and the BP using the smartwatch
Time frame: Baseline
Correlation of nighttime dipping between the ABPM and the BP using the smartwatch
Time frame: Baseline
Correlation of morning BP between the ABPM and the BP using the smartwatch
Wonju Severance Christian Hospital
Other
Correlation Between Smartwatch-based Blood Pressure Monitoring and Conventional Ambulatory Blood Pressure Monitoring
Acronym: SamsungWatch
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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