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