Accuracy of Cuffless Ambulatory Blood Pressure Monitors Compared to Cuff-based Monitors in an Ambulatory Elderly Population: A Pilot Study

Summary

Hypertension is extremely common amongst the elderly, typically manifesting as a silent disease with potentially devastating consequences if left undetected and untreated. Such consequences include stroke, myocardial infarction, kidney and eye disease. Opportunistic screening for hypertension is therefore standard in clinical practice. Currently, the standard of care for screening in the western world is with 24-hour ambulatory cuff-based devices which are often intolerable, particularly for elderly patients.

Several novel cuffless wearables have been developed to overcome the limitations of cuff-based monitors. These devices offer significant advantages over cuff-based devices, including improved patient tolerance and user acceptability. Numerous cuffless monitors are now commercially available. However, validation of such devices is challenging as there is no current universal standard for validating such devices.5 This is highlighted by the heterogenous and often inadequate study methods used to demonstrate accuracy of commercially available cuffless devices for blood pressure measurements. Indeed, the uncertainty about their merit is reflected in international guidelines. The 2023 European Society of Hypertension guidelines currently do not recommend routine use of such devices in clinical practice for evaluation of blood pressure.

There are limited clinical trials comparing 24-hour cuff-based devices directly to cuffless devices, and even fewer specifically in an elderly population where they may be particularly advantageous due to design features that improve tolerability. This study thus aims to address this important gap in the literature to better understand if cuffless devices provide reliable blood pressure measurements in the elderly population by directly comparing these devices to the current standard of care in blood pressure evaluation. The Aktiia device will be used as a surrogate for cuffless wearables while a standard 24-hour ambulatory cuff-based device will represent cuff-based devices. The Aktiia device is a cuffless solution worn as a bracelet on the wrist. It contains optical sensors which collect photoplethysmography signals from arteries in the patient's wrist and uses these to estimate blood pressure. This device is commercially available and clinically validated for use in patients up to age 85.

Conditions

• Hypertension

Interventions

DEVICE

Aktiia SA Bracelet

The Aktiia device is a wearable blood pressure monitor developed by the company Aktiia SA. It is designed to monitor at blood pressure frequent intervals throughout the day and night without the need for inflatable cuffs. Instead, it contains optical sensors which collect photoplethysmography signals from arteries in the patient's wrist and uses these to estimate blood pressure. The device only takes measurements when it perceived optimal conditions for doing so, corresponding to minimal arm movement (i.e. a resting state) for at least five minutes and good quality signal detection. This device is commercially available and validated for use in adults aged 85 and younger.

Sponsors & Collaborators

• Sligo General Hospital

  lead OTHER

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-15

Primary Completion

2024-08-30

Completion

2024-09-30