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iPhone App Compared to Standard RR-measurement (iPARR)

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ClinicalTrials.gov Identifier: NCT02552030
Recruitment Status : Completed
First Posted : September 16, 2015
Last Update Posted : February 14, 2017
Sponsor:
Collaborator:
Preventicus GmbH
Information provided by (Responsible Party):
Jens Eckstein, University Hospital, Basel, Switzerland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Blood Pressure Device: cuff device (Omron HBP-1300-E Pro) Device: iPhone 4s Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1019 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: iPhone App Compared to Standard RR-measurement - iPARR Trial
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : April 25, 2016
Actual Study Completion Date : December 31, 2016

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Percent of invalid measurements [ Time Frame: 1 day ]
    Percent of measurements that cannot be used for analysis

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Atrial fibrillation
  • Dialysis shunt

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552030


Locations
Switzerland
Universityhospital
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
Jens Eckstein
Preventicus GmbH
Investigators
Principal Investigator: Jens Eckstein, MD, PhD University Hospital, Basel, Switzerland