24-hour wearable blood pressure monitoring comparison
Wearable Evaluation of Ambulatory Readings for Blood Pressure
We will test if wearable cuffless and cuff-based devices can reliably measure blood pressure over 24 hours compared with a standard ambulatory cuff monitor in adults with normal or high blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06610448 on ClinicalTrials.gov |
What this trial studies
Adults from the Boston area will wear multiple blood pressure and activity monitors for two consecutive days to compare novel cuffless and wrist-based devices with a Spacelabs ambulatory cuff monitor. Up to 250 participants (at least 100) will each wear up to seven devices, with device assignment randomized by day and by the arm or wrist on which devices are worn. On the first visit participants are fitted with three BP devices (including Spacelabs ABPM or ABPMpro, the Aktiia wristband, and a cuff-based wrist monitor) plus an activity monitor, and on the second visit they wear a different set including a chest patch ABPM. Continuous 24-hour recordings including overnight data will be collected and compared to determine device accuracy across daily activities and positions.
Who should consider this trial
Good fit: Adults aged 18–100 who live in the Boston area, can provide informed consent, have two arms, and can tolerate wearing multiple BP devices for 24 hours are ideal candidates.
Not a fit: People with arm circumferences over 50 cm, those unable to wear the devices or complete the procedures, or those who cannot travel to Boston for study visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, accurate cuffless wearables could make 24-hour blood pressure monitoring easier and more widely available, improving diagnosis and management of hypertension.
How similar studies have performed: Previous work on cuffless and wrist blood pressure monitors has produced mixed results, with some promising devices but inconsistent validation against standard ambulatory cuff monitors.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Stephen P. Juraschek, MD, PhD
- Email: sjurasch@bidmc.harvard.edu
- Phone: 617-754-1416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.