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Completed

NCT Number: NCT02552030

iPhone App Compared to Standard RR-measurement

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.

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Key information

Conditions

Hypertension Blood Pressure Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universityhospital

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Atrial fibrillation
  • Dialysis shunt

Treatment and study plan

cuff device (Omron HBP-1300-E Pro)

Device

Comparison of systolic blood pressure results measured with an oscillometric cuff device (Omron HBP-1300-E Pro) and iPhone 4s

iPhone 4s

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jens Eckstein

Other

Collaborators

  • Preventicus GmbH

Registry information

Official study title

iPhone App Compared to Standard RR-measurement - iPARR Trial

Acronym: iPARR

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2015
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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