iPhone App Compared to Standard Riva-Rocci (RR)-Measurement During Stress Testing

Overview

The iPARR DELTA BP Study is designed to evaluate whether a new smartphone app using the photoplethysmography signal of the inbuilt camera can measure blood pressure (BP) fluctuations with sufficient correlation compared to the goldstandard oscillometric BP measurements. Investigators will recruit patients who are scheduled for a routine treadmill stress test and assess their blood pressure before and right after the test with the smartphone app and the standard BP measurements on the opposite upper extremity. Pronounced BP fluctuations are encountered during vigorous activities. The primary endpoint of the iPARR DELTA BP Study is the correlation of the absolute difference of subsequent measurements between both techniques. If the relative chances of BP fluctuations are sufficiently assessed with this new device, BP fluctuations could be monitored continuously after calibration.

Full Title of Study: “iPhone App Compared to Standard RR-measurement During Stress Testing”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2017

Interventions

  • Device: cuff device
    • Measurement of blood pressure during stress testing with cuff device
  • Device: iphone
    • Measurement of blood pressure during stress testing with iPhone

Arms, Groups and Cohorts

  • Experimental: Blood pressure measurement
    • six repetitive blood pressure measurements with iPhone and conventional oscillometric cuff device during stress testing will be performed

Clinical Trial Outcome Measures

Primary Measures

  • Absolute difference between conventional blood pressure measurements and the corresponding iPhone blood pressure estimations
    • Time Frame: 1 day
    • Difference between the delta of two sequential oscillometric measurements and the delta of the two corresponding blood pressure estimates calculated from the PPG signal of an iPhone 4S

Secondary Measures

  • Number of measurement failures
    • Time Frame: 1 day
    • Number of measurements that cannot be analyzed due to bad signal quality of the Photoplethysmography (PPG) signal

Participating in This Clinical Trial

Inclusion Criteria

  • able to give informed consent Exclusion Criteria:

  • atrial fibrillation – medical reasons why blood pressure measurement is not possible at the upper extremity (Shunt, Lymphedema)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jens Eckstein, MD, PhD, Principal Investigator, University Hospital, Basel, Switzerland

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