iPhone App Compared to Standard RR-measurement

Not Applicable

Completed

• Conditions: Hypertension; Blood Pressure
• Interventions: Device: cuff device (Omron HBP-1300-E Pro); Device: iPhone 4s

• Registration Number: NCT02552030
• Lead Sponsor: Jens Eckstein

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.

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 Timeline

• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-16
• Study Start: 2015-10-01
• Primary Completion: 2016-04-25
• Study Completion: 2016-12-31
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1019

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood pressure-measurement	iPhone 4s	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)'
Blood pressure-measurement	cuff device (Omron HBP-1300-E Pro)	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)'

Primary Outcome Measures

Name	Time	Method
Absolute difference between systolic blood pressure values determined with an oscillometric cuff device and an iPhone 4s (Delta mmHg)	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

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

Trial Locations

Locations (1)

Universityhospital; 🇨🇭 Basel, BS, Switzerland