Clinical Trial of Digital Therapeutics (One.Dr) for Suspected Orthostatic Hypotension Patients
NCT07348445 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2026-01-16
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
- 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
Sponsors & Collaborators
-
Yonsei University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-31
- Primary Completion
- 2026-04-30
- Completion
- 2026-04-30
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