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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
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.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
January 1, 2026
Primary Completion Date
April 1, 2026
Completion Date
April 1, 2026
Last Updated
January 16, 2026
86
ESTIMATED participants
Digital therapeutics (One.Dr Application)
OTHER
Digital therapeutics (Sham Application)
OTHER
Lead Sponsor
Yonsei University
NCT07481851
NCT05707442
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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