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Clinical Trial of Digital Therapeutics (One.Dr) for Suspected Orthostatic Hypotension Patients
Sponsor: Yonsei University
Summary
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.
Official title: A Single-center, Randomized, Double-blind, Sham-controlled, Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of the Digital Therapeutics (One.Dr) to Improve Blood Pressure Drop When Standing in Patients With Suspected Orthostatic Hypotension
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2026-01
Completion Date
2026-04
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
Digital therapeutics (One.Dr Application)
An application that provides educations and non-pharmaceutical treatment (participant customized content) for orthostatic hypotension via a smart device
Digital therapeutics (Sham Application)
An application that provides general health knowledge via a smart device