Accuracy Testing of Validated and Non-validated Home BP Devices Sold on the Online Market.

Comparing Home Blood Pressure Measurements from Devices with and Without Evidence of Validation to Ambulatory Blood Pressure Monitoring: the VALID-HomeBP Study

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06688409

Acronym

VALID-HomeBP

Enrollment

140

Registered

2024-11-14

Start date

2024-02-12

Completion date

2027-11-30

Last updated

2025-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, blood pressure measurement, blood pressure, blood pressure device validation

Brief summary

This study aims to assess whether validated and non-validated blood pressure measuring devices sold on the online market are accurate in regards to the mean awake BP from ambulatory blood pressure monitoring.

Interventions

DIAGNOSTIC_TESTawake ABPM

Comparison of a BP measured with the home BP devices and the average awake ABPM performed immediately after

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adults aged \> 18 years scheduled to undergo an ABPM

Exclusion criteria

* Upper arm size outside of cuff range of selected devices (\<22 cm or \>42 cm) * Night shift workers * Permanent atrial fibrillation * Known severe aortic stenosis * Contraindication to measure BP on the non-dominant arm * Ongoing pregnancy * Inability or unwillingness to provide consent

Design outcomes

Primary

Measure	Time frame	Description
Mean difference in systolic BP	At enrollment (time 0)	Mean difference in systolic BP between the home BP device and the awake ABPM

Secondary

Measure	Time frame	Description
Mean difference in diastolic BP	At enrollment (time 0)	Mean difference in diastolic BP between the home BP device and the awake ABPM
Mean difference in systolic BP from validated device	At enrollment (time 0)	Mean difference in systolic BP between the non-validated home BP device and the validated home BP device
Mean difference in diastolic BP from validated device	At enrollment (time 0)	Mean difference in diastolic BP between the non-validated home BP device and the validated home BP device

Countries

Canada

Contacts

Primary ContactRemi Goupil, MD MSc

remi.goupil@umontreal.ca514-338-2883

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026