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NCT02552030 Clinical Trial

iPhone App Compared to Standard RR-measurement

Hypertension Clinical Trial

— iPARR  

Official title:
iPhone App Compared to Standard RR-measurement - iPARR Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02552030
Other study ID # EKNZ 2015-287
Secondary ID
Status Completed
Phase N/A
First received September 14, 2015
Last updated February 13, 2017
Start date October 1, 2015
Est. completion date December 31, 2016

Study information
Verified date February 2017
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1019
Est. completion date December 31, 2016
Est. primary completion date April 25, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- able to give informed consent

- in Sinus rhythm

- no anatomical limitation to take blood pressure

Exclusion Criteria:

- Atrial fibrillation

- Dialysis shunt

Study Design

Related Conditions & MeSH terms

Intervention

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
• iPhone 4s

Locations
Country Name City State
Switzerland Universityhospital Basel BS

Sponsors (2)
Lead Sponsor Collaborator
Jens Eckstein Preventicus GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Percent of invalid measurements Percent of measurements that cannot be used for analysis 1 day
Secondary 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
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