Wearable Evaluation of Ambulatory Readings for Blood Pressure

Not Applicable

Not yet recruiting

• Conditions: Normal Blood Pressure; Controlled Hypertension; Uncontrolled Hypertension
• Interventions: Device: ABPMPro; Device: Aktiia Blood Pressure; Device: Spacelabs Ambulatory Blood Pressure Monitoring; Device: LiveMetric; Device: Bpro

• Registration Number: NCT06610448
• Lead Sponsor: Stephen Juraschek

Brief Summary

The purpose of this project is to compare the performance and validity of novel wearable technologies that measure blood pressure (BP) and physical activity with a Spacelabs Ambulatory Blood Pressure Monitoring (ABPM) device.

Detailed Description

The investigators will recruit community-dwelling participants to wear novel cuffless BP monitoring devices for comparison with a Spacelabs ABPM device throughout a 24-hour period. The identification of accurate cuffless BP technologies would greatly improve access to ABPM and allow for BP measurements at times when the use of cuff-based devices are not feasible. Knowledge from this project will inform subsequent research protocols among adults and under-represented groups.

Up to 250 participants (at least 100) will be involved in this study each wearing up to 7 devices (6 BP devices and 1 activity monitor). The assignment of devices will be randomized by day and by the arm or wrist on which they are worn. During the first visit, participants will provide their consent and be randomly fitted with 3 BP devices; either the Spacelabs ABPM device or the ABPMpro device, the Aktiia wristband BP monitor, and one of two other cuff-based wrist BP monitors, along with an activity monitor to track body positions. These devices will be worn continuously for at least 24-hours, including overnight, before being returned. On the following day, for Visit 2, participants will be fitted with a different set of 3 BP devices; the ABPMpro device or Spacelabs ABPM device, the Aktiia wristband BP device (on the opposite wrist from the previous day), and the final cuff-based wristband BP device. Additionally, participants will wear an ambulatory BP device as a patch on the chest. These devices will also be worn for at least 24 hours. This study will enable characterization of the feasibility, practicality, and effectiveness of the measurements and the devices\' accuracy and precision.

Study Timeline

• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-24
• Status Verified: 2025-05
• Study Start: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-05-03
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age 18 to 100 years
• All neighborhoods in Boston area
• Be able to walk with two limbs and have two arms
• Willing and able to complete required measurement procedures
• Able to provide informed consent

Exclusion Criteria

• Failure to receive informed consent
• Arm circumference of more than 50cm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cuff-based ambulatory blood pressure monitor sequence	ABPMPro	Participants will be randomized 1:1 to wear (A) the Spacelabs ambulatory blood pressure monitor on the first day and ABPMPro ambulatory blood pressure monitor on the second day or (B) ABPMPro ambulatory blood pressure monitor on the first day then Spacelabs ambulatory blood pressure monitor on the second day.
Cuff-based ambulatory blood pressure monitor sequence	Spacelabs Ambulatory Blood Pressure Monitoring	Participants will be randomized 1:1 to wear (A) the Spacelabs ambulatory blood pressure monitor on the first day and ABPMPro ambulatory blood pressure monitor on the second day or (B) ABPMPro ambulatory blood pressure monitor on the first day then Spacelabs ambulatory blood pressure monitor on the second day.
Left versus right upper limb	Aktiia Blood Pressure	Participants will be randomized to wear the Aktiia cuffless blood pressure device on either the left upper limb versus the right upper limb on the first day. On the second day, the Aktiia blood pressure device will be switched to the other arm which did not get randomized on the first day. Another wristband (LiveMetric versus Bpro) will be worn on the contralateral arm.
Left versus right upper limb	LiveMetric	Participants will be randomized to wear the Aktiia cuffless blood pressure device on either the left upper limb versus the right upper limb on the first day. On the second day, the Aktiia blood pressure device will be switched to the other arm which did not get randomized on the first day. Another wristband (LiveMetric versus Bpro) will be worn on the contralateral arm.
Left versus right upper limb	Bpro	Participants will be randomized to wear the Aktiia cuffless blood pressure device on either the left upper limb versus the right upper limb on the first day. On the second day, the Aktiia blood pressure device will be switched to the other arm which did not get randomized on the first day. Another wristband (LiveMetric versus Bpro) will be worn on the contralateral arm.
Wristband sequence (first day versus second day)	Aktiia Blood Pressure	Participants will be randomized 1:1 to wear (A) the LiveMetric wristband on the first day and Bpro wristband on the second day or (B) Bpro wristband on the first day then LiveMetric wristband on the second day. The arm side (i.e., right or left) will be determined by the Aktiia cuffless blood pressure device randomization on the first day. For the second day, the Aktiia cuffless blood pressure device will be worn on the arm opposite the first day with the other device (LiveMetric versus Bpro) worn on the contralateral arm.
Wristband sequence (first day versus second day)	LiveMetric	Participants will be randomized 1:1 to wear (A) the LiveMetric wristband on the first day and Bpro wristband on the second day or (B) Bpro wristband on the first day then LiveMetric wristband on the second day. The arm side (i.e., right or left) will be determined by the Aktiia cuffless blood pressure device randomization on the first day. For the second day, the Aktiia cuffless blood pressure device will be worn on the arm opposite the first day with the other device (LiveMetric versus Bpro) worn on the contralateral arm.
Wristband sequence (first day versus second day)	Bpro	Participants will be randomized 1:1 to wear (A) the LiveMetric wristband on the first day and Bpro wristband on the second day or (B) Bpro wristband on the first day then LiveMetric wristband on the second day. The arm side (i.e., right or left) will be determined by the Aktiia cuffless blood pressure device randomization on the first day. For the second day, the Aktiia cuffless blood pressure device will be worn on the arm opposite the first day with the other device (LiveMetric versus Bpro) worn on the contralateral arm.

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	24 - 48 hours	Measured from all 5 randomized devices

Secondary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure	24 - 48 hours	Measured from all 5 randomized devices
Heart Rate	24 - 48 hours	Measured from all 5 randomized devices
ActivPaL device (Physical activity monitor)	24 - 48 hours	Physical activity intensity and type of activity will be characterized throughout the 48hr wear period. While the investigators are interested in the impact of devices on activity, the investigators are also interested in the relationship between activities and blood pressure.