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CompletedNCT06688409VALID-HomeBPUpdated Oct 21, 2026

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

An interventional study of awake ABPM in Hypertension, sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Feb 2024, registered Nov 2024).
Updated Oct 21, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension

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Keywords

  • hypertension
  • blood pressure measurement
  • blood pressure
  • blood pressure device validation
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 140 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal is the lead sponsor of 32 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged > 18 years scheduled to undergo an ABPM

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
140 participants (actual)

Study arms

  • Active comparator
    Validate home BP device

    BP measured with a validated home BP device

    Diagnostic Test: awake ABPM

  • Active comparator
    Non-validated home BP device #1

    BP measured with the first non-validated home BP device

    Diagnostic Test: awake ABPM

  • Active comparator
    Non-validated home BP device #2

    BP measured with the second non-validated home BP device

    Diagnostic Test: awake ABPM

  • Active comparator
    Non-validated home BP device #3

    BP measured with the third non-validated home BP device

    Diagnostic Test: awake ABPM

Interventions

  • Diagnostic testawake ABPM

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

06

What researchers measure

Primary outcomes

  1. Mean difference in systolic BP

    Mean difference in systolic BP between the home BP device and the awake ABPM

    Time frame: At enrollment (time 0)

Secondary outcomes

  1. Mean difference in diastolic BP

    Mean difference in diastolic BP between the home BP device and the awake ABPM

    Time frame: At enrollment (time 0)

  2. Mean difference in systolic BP from validated device

    Mean difference in systolic BP between the non-validated home BP device and the validated home BP device

    Time frame: At enrollment (time 0)

  3. Mean difference in diastolic BP from validated device

    Mean difference in diastolic BP between the non-validated home BP device and the validated home BP device

    Time frame: At enrollment (time 0)

07

Study locations

1 site
  • Hôpital Sacré-Coeur de Montréal
    Montreal, Quebec H4J 1C5, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 21, 2026
Primary completion
Nov 30, 2027→Oct 15, 2026 (actual)
Oct 21, 2026
Study completion
Nov 30, 2027→Oct 15, 2026 (actual)
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    Recruiting→Completed
    Primary completion Nov 30, 2027→Oct 15, 2026 (now actual)
    Study completion Nov 30, 2027→Oct 15, 2026 (now actual)
    + 5 other changes: identifiers, verification date, oversight details, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06688409
Lead sponsor
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Responsible party
Remi Goupil, MD MSc (Principal investigator, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal) — Principal investigator
First posted
Nov 14, 2024
Start date
Feb 12, 2024
Primary completion
Oct 15, 2026
Completion
Oct 15, 2026
Last update
Oct 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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