Clinical trial NCT06358378: Accuracy of Cuffless Ambulatory Blood Pressure Monitors Compared to Cuff-based Monitors in an Ambulatory Elderly Population: A Pilot Study
Official title: Accuracy of Cuffless Ambulatory Blood Pressure Monitors Compared to Cuff-based Monitors in an Ambulatory Elderly Population: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Sligo General Hospital
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Adults \>65 years old
* Enrolled on Sligo/Leitrim ICPOP programme
* Participants (or carers) must have access to a smart phone compatible with the Aktiia app

Exclusion Criteria:

* Cognitive impairment or diagnosis of dementia
* Adults unable to provide informed consent
* Life-expectancy less than one year
* Patient's unlikely to comply with trial protocol in opinion of investigator's

Primary outcomes:
measure: Mean paired difference between cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements
timeFrame: 4 months
Secondary outcomes:
measure: Mean paired difference between cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements taken in a resting state
timeFrame: 4 months
measure: Mean difference between mean 24-hour cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements on a per patient basis
timeFrame: 4 months
measure: Tolerability : Mean paired differences on Comfort Rating Scale (CRS) between devices
timeFrame: 4 months
measure: User Acceptability: Mean paired differences on System Usability Scale (SUS) between devices
timeFrame: 4 months
Other outcomes:
measure: Proportion of recruited patients who provide at least 5 daytime cuffless blood pressure readings per day
timeFrame: 4 months
measure: Proportion of total measurements taken which can be paired (i.e. taken within 1-hour of a measurement from the other device)
timeFrame: 4 months
measure: Proportion of missing data from activity diaries
timeFrame: 4 months
measure: Proportion of recruited patients who provide at least 3 paired blood pressure readings for 3 consecutive days
timeFrame: 4 months
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