NCT07348445

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypotension
• Orthostasis

Interventions

Type	Name	Description
OTHER	Digital therapeutics (One.Dr Application)	An application that provides educations and non-pharmaceutical treatment (participant customized content) for orthostatic hypotension via a smart device
OTHER	Digital therapeutics (Sham Application)	An application that provides general health knowledge via a smart device

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2026-01-16
• Last updated: 2026-01-16