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

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged > 18 years scheduled to undergo an ABPM

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • awake ABPM

    Diagnostic test

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

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: Validate home BP deviceActive comparator 1 intervention
Group B: Non-validated home BP device #1Active comparator 1 intervention
Group C: Non-validated home BP device #2Active comparator 1 intervention
Group D: Non-validated home BP device #3Active comparator 1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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