Screening for Masked Hypertension With Smart Wearable Devices (SMART) (SMART)

Screening for Masked Hypertension in Young and Middle-aged Adults With Smart Wearable Devices (SMART)

In recent years, a large number of consumer-grade and Smart Wearable Devices (SWD) such as smart watches, with BP measurement property, have entered the market and have a high configuration and utilization among young and middle-aged populations, but most of them are uncalibrated and have poor accuracy. Recently, several medical-grade smart BP watches have passed the national medical device registration test, which will provide an important tool for accurate screening of hypertension, especially masked hypertension, in young and middle-aged people.

"Screening for masked hypertension in young and middle-aged adults with smart wearable devices" （SMART）aims to screen for masked hypertension using smart BP watches that have been tested for national medical device registration. It is planned to include 200 young and middle-aged subjects with normal blood pressure (BP) in the clinic, who will wear the smart BP watch for 7 consecutive days (BP will be measured at least once in the morning and once in the evening, 2-3 times each time), and if the mean BP is >= 135/85 mmHg, it will be determined to be MK and recommended for further consultation and treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Masked Hypertension
• Intervention / Treatment: Device: smart wearable device

Detailed Description

Masked hypertension (MH) is defined as elevated ambulatory or home blood pressure (BP), but normal office BP, often complicated with severe cardiovascular and renal damage. MH is easily missed and needs to be identified by "out-of-office" BP measurements such as ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM). However, in clinical practice, ABPM has poor accessibility, high cost, and requires appointments, making it difficult to meet the demand; HBPM has better accessibility, but low utilization and irregular use are more prominent. In addition, these devices interfere with sleep and activity when measuring BP, so their clinical application is somewhat limited.

Smart wearable devices (SWD) can sense and record various physiological parameters of human body, and analyze the health status of individuals with the support of software algorithms. In recent years, a large number of consumer-grade and SWD such as smart watches, with BP measurement property, have entered the market and have a high configuration and utilization among young and middle-aged populations, but most of them are uncalibrated and have poor accuracy. Recently, several medical-grade smart BP watches have passed the national medical device registration test, which will provide an important tool for accurate screening of hypertension, especially MH, in young and middle-aged people.

"Screening for masked hypertension in young and middle-aged adults with smart wearable devices" （SMART） aims to screen for MH using smart BP watches that have been tested for national medical device registration. It is planned to include 200 young and middle-aged subjects with normal blood pressure in the clinic, who will wear the smart BP watch for 7 consecutive days (BP will be measured at least once in the morning and once in the evening, 2-3 times each time), and if the mean BP is >= 135/85 mmHg, it will be determined to be MK and recommended for further consultation and treatment.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
    • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited in the hospital in the volunteers who are interested in this project or those who are concern of the hypertension despite with norm tension during usual physical examinations.

Description

Inclusion Criteria:

1. 18-50 years of age, male or female
2. No clear previous history of hypertension and other cardiovascular diseases
3. Signed informed consent form

Exclusion Criteria:

1. Patients with established hypertension
2. History of severe heart, liver, or kidney disease
3. Inability to cooperate in completing the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of masked hypertension	Average systolic/diastolic BP during 7 days of the observation period will be calculated. Office BP should be measured when the average BP is ≥135/85 mmHg during 7 days of continuous self-monitoring. If the office BP is < 140/90 mmHg at visit, "Masked Hypertension" will be diagnosed. The prevalence of masked hypertension will be calculated as the following: number of masked hypertension/number of subjects included.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of hypertension	Average systolic/diastolic BP during 7 days of the observation period will be calculated. Office BP should be measured when the average BP is ≥135/85 mmHg during 7 days of continuous self-monitoring. If the office BP is ≥140/90 mmHg at visit, the diagnosis will be "Hypertension". The prevalence of hypertension will be calculated as the following: number of hypertension/number of subjects included.	7 days

Collaborators and Investigators

• Sponsor: Jing Liu
• Collaborators: HUAWEI

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): July 1, 2024

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (ACTUAL): June 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: asked hypertension, Smart wearable device
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Masked Hypertension
• Other Study ID Numbers: 2022PHB108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No