Image

Evaluating the Level of Agreement Between AAMI/ESH/ISO Universal Standard Requirements and the HUAWEI D2 Watch-Type Wrist Blood Pressure Monitor

Evaluating the Level of Agreement Between AAMI/ESH/ISO Universal Standard Requirements and the HUAWEI D2 Watch-Type Wrist Blood Pressure Monitor

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

Getting an accurate blood pressure (BP) reading is essential for diagnosing high blood pressure and managing it effectively. High blood pressure is a major health problem, causing about 9.4 million deaths worldwide each year. More people need to monitor their BP at home, so there is greater demand for easy-to-use devices. Traditional BP monitors with arm cuffs can be bulky, uncomfortable, and awkward to use.

Modern technology has made it possible to measure BP using wearable devices like smartwatches. HUAWEI has developed a wrist watch that can measure BP and has been tested to meet international standards. The watch passed these tests and was approved for people to use at home to check their own BP. However, the HUAWEI watch was only tested on people in China and the investigators need to know if it works for people from other countries and ethnic backgrounds.

Description

Accurate measurement of blood pressure (BP) is a necessity for the reliable diagnosis and proficient management of hypertension. However, validation of blood pressure monitoring devices only began in the 1980's, followed by a series of ad-hoc validation protocols from differing organisations such as the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society (BHS), the German Hypertension League, the European Society of Hypertension (ESH), and the International Organisation for Standardization (ISO) over the subsequent three decades. The need for a universally acceptable protocol was recognised and members of the AAMI, ESH, and ISO committees collaborated to re-examine the aspects of validation to achieve a consensus on an optimal validation standard.

With an increased prevalence of hypertension, causing approximately 9.4 million deaths per year worldwide, the demand for non-invasive arterial pressure monitoring devices has also increased to help patients manage blood pressure (BP). Traditionally, non-invasive BP measurement techniques include auscultatory and oscillometric devices, however, these can present with several limitations in terms of cuff size, instruments' bulky volume, and discomfort caused by external pressure. Advancements in technology has meant that wearable devices are becoming readily available for various health related measurements, including BP. The HUAWEI Technology have developed an automated oscillometric wearable wrist watch-type device for BP measurement that has recently been validated in accordance with the AAMI/ESH/ISO Universal Standard requirements and can be recommended for self-measurement. However, while this research concluded the HUAWEI watch fulfilled the requirements for self-measurement in the general population, it should be noted that the study was conducted within the Chinese population only. Consequently, to ensure generalisation to a wider population, it is important to examine the HUAWEI watch validity within differing populations. Therefore, the aim of this study will be to explore if the HUAWEI D2 watch-type blood pressure monitor meets the AAMI/ESH/ISO Universal Standard requirements in differing populations.

Eligibility

Inclusion Criteria:

  • Age \>18 years
  • Written informed consent provided

Exclusion Criteria:

  • Cardiac Arrythmias
  • Peripheral Arterial Disease
  • Known Heart Disease
  • Pregnancy
  • Diagnosis of Secondary Hypertension

Study details
    Blood Pressure Monitoring

NCT07297277

Northumbria University

1 February 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.