Clinical Trial of Digital Therapeutics (One.Dr) for Suspected Orthostatic Hypotension Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University

About this trial

Participants who meet the inclusion/exclusion criteria in the Screening visit are randomly assigned 1:1 to the treatment group or the sham control group. The two-week period after Screening is the Run-in period, and the participant performs self-measured blood pressure monitoring, records data using the One.Dr application, and records symptoms and events related to orthostatic hypotension such as dizziness in the application. Only those who have completed the Run-in period will enter the Intervention period (for 6 weeks at 3-8 weeks), and according to each allocation group, non-pharmaceutical treatment education is provided for the treatment group and general health knowledge education is provided for the sham control group.

Eligibility criteria

Qualifiers

Adults over 19 years of age suspected of orthostatic hypotension due to symptoms such as dizziness within one year

Participants who are able to walk and conduct this clinical trial or cooperate with their care providers

Disqualifiers

Participants diagnosed with diseases that cause dizziness other than orthostatic hypotension, such as otolithiasis and stroke, within one year

Severe anemia (Hb <8.0 g/dL, based on the latest test results within 12 months)

Participants unable to use smartphones (android phones) and/or smart watches

Participants with chronic diseases less than one year of life expectancy, such as malignant tumors

Trial design

Treatments tested in this trial

  • Digital therapeutics (One.Dr Application)
  • Digital therapeutics (Sham Application)

Treatment groups

86 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators