iPhone App Compared to Standard RR-measurement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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iPhone App Compared to Standard RR-measurement - iPARR Trial

Conditions
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Hypertension, Blood Pressure

Intervention / Treatment
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* Device: cuff device (Omron HBP-1300-E Pro)
* Device: iPhone 4s


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: able to give informed consent in Sinus rhythm no anatomical limitation to take blood pressure Exclusion Criteria: Atrial fibrillation Dialysis shunt

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood pressure-measurement<br>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)<br>* Comparison of systolic blood pressure results measured with an oscillometric cuff device (Omron HBP-1300-E Pro) and iPhone 4s<br>Device: iPhone 4s<br> <br> |

What is the study measuring?
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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) | 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 | 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 | 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. | Quantitative differences between the accuracy of the iPhone measurements in the patients with known arteriosclerosis and the patients without arteriosclerosis | 1 day |