Clinical trial NCT05409898: Screening for Masked Hypertension With Smart Wearable Devices (SMART)
Official title: Screening for Masked Hypertension in Young and Middle-aged Adults With Smart Wearable Devices (SMART)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Masked Hypertension
Keywords: asked hypertension, Smart wearable device
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: HUAWEI
First posted: 2022-06-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of masked hypertension
timeFrame: 7 days
Secondary outcomes:
measure: Prevalence of hypertension
timeFrame: 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Jing Liu, MD
role: STUDY_CHAIR
References: