iPhone App Compared to Standard RR-measurement (iPARR)

February 13, 2017 updated by: Jens Eckstein

iPhone App Compared to Standard RR-measurement - iPARR Trial

In this Trial we compare a new application (App) running on an iPhone (Apple inc., Model 4S) to determine systolic blood pressure (RR) and compare it to conventional oscillometric measurements using an Omron HBP-1300-E Pro device. We will include 1000 participants and perform seven repetitive blood pressure measurements (3 iPhone, 4 Omron) in each person. Primary parameter will be the absolute difference (Delta) between the correlating blood pressure measurements in mmHg.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be asked for consent at the University Hospital Basel at random based on availability. Recruitment is not limited to patients. After consenting patients will accompanied to a RR-measurement unit, positioned in a chair and kept at rest for 4 minutes. Then 7 blood pressure measurements at the same arm will be performed (Cuff/iPhone/Cuff/iPhone/Cuff/iPhone/Cuff). The Cuff measurement results will be documented in the source documents (mmHg) and transferred to a trial database. The iPhone data will be transferred with patient ID to "Preventicus" for calculation of the systolic blood pressure values (mmHg) based on the pulse waves recorded by transillumination of the index fingers of the participants. "Preventicus" will have NO access to the Cuff-measurement data. Then this data will be retransferred to the trial site and merged with help of the patient ID. Absolute and relative differences of the measured (Omron) and calculated (iPhone) systolic blood pressure values (mmHg) for will be calculated and published.

A subgroup of 40 participants will be evaluated in a highly standardized fashion according the ESH (European Society Hypertension) guidelines for validation studies. These data will then be published separately for validation purposes.

Study Type

Interventional

Enrollment (Actual)

1019

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • BS
      • Basel, BS, Switzerland, 4031
        • Universityhospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • able to give informed consent
  • in Sinus rhythm
  • no anatomical limitation to take blood pressure

Exclusion Criteria:

  • Atrial fibrillation
  • Dialysis shunt

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood pressure-measurement
Seven repetitive blood pressure measurements will be performed the left or right arm of all participants with an iPhone 4s and a conventional oscillometric device 'cuff device (Omron HBP-1300-E Pro)'
Device: cuff device (Omron HBP-1300-E Pro)
Comparison of systolic blood pressure results measured with an oscillometric cuff device (Omron HBP-1300-E Pro) and iPhone 4s
Device: iPhone 4s

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute difference between systolic blood pressure values determined with an oscillometric cuff device and an iPhone 4s (Delta mmHg)
Time Frame: 1 day
In each participant seven repetitive blood pressure measurements will be performed. Starting with a conventional cuff measurement followed by an iPhone measurement, followed by a conventional cuff measurement and so on. Then the absolute difference between each pair of successive measurements will be calculated. These differences will then be averaged and documented as primary result.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative difference between oscillometric blood pressure measurement and iPhone based blood pressure measurement
Time Frame: 1 day
Same as primary outcome, but calculation of delta (mmHg) and documentation as relative value (%) of the absolute systolic value.
1 day
Percent of invalid measurements
Time Frame: 1 day
Percent of measurements that cannot be used for analysis
1 day
Comparison of primary outcome in the subgroup of patients with atherosclerosis compared to the participants without arteriosclerosis.
Time Frame: 1 day
Quantitative differences between the accuracy of the iPhone measurements in the patients with known arteriosclerosis and the patients without arteriosclerosis
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jens Eckstein

Collaborators

Preventicus GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

April 25, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNZ 2015-287

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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