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

NCT ID: NCT06688409

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-12

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Validate home BP device

BP measured with a validated home BP device

Group Type ACTIVE_COMPARATOR

awake ABPM

Intervention Type DIAGNOSTIC_TEST

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

Non-validated home BP device #1

BP measured with the first non-validated home BP device

Group Type ACTIVE_COMPARATOR

awake ABPM

Intervention Type DIAGNOSTIC_TEST

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

Non-validated home BP device #2

BP measured with the second non-validated home BP device

Group Type ACTIVE_COMPARATOR

awake ABPM

Intervention Type DIAGNOSTIC_TEST

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

Non-validated home BP device #3

BP measured with the third non-validated home BP device

Group Type ACTIVE_COMPARATOR

awake ABPM

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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awake ABPM

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

OTHER

Sponsor Role lead

Responsible Party

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Remi Goupil, MD MSc

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Remi Goupil, MD MSc

Role: CONTACT

514-338-2883

Facility Contacts

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Guylaine Marcotte

Role: primary

+1-514-338-2222

Other Identifiers

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VALID-HomeBP

Identifier Type: -

Identifier Source: org_study_id

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