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

January 9, 2026 updated by: Yonsei University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults over 19 years of age suspected of orthostatic hypotension due to symptoms such as dizziness within one year
  2. Participants who are able to walk and conduct this clinical trial or cooperate with their care providers

Exclusion Criteria:

  1. Participants diagnosed with diseases that cause dizziness other than orthostatic hypotension, such as otolithiasis and stroke, within one year
  2. Severe anemia (Hb <8.0 g/dL, based on the latest test results within 12 months)
  3. Participants unable to use smartphones (android phones) and/or smart watches
  4. Participants with chronic diseases less than one year of life expectancy, such as malignant tumors
  5. Participants with severe heart valve disease or severe heart failure (LVEF <35%) who have been hospitalized for acute exacerbation within the last 3 months
  6. Participants with recent rapid and unintended weight loss (5% or more than 5 kg within 6 months)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One.Dr Application
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
Sham Comparator: Sham Application
Other: Digital therapeutics (Sham Application)
An application that provides general health knowledge via a smart device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in orthostatic SBP or DBP drop between the Run-in period and the Intervetion period
Time Frame: For 8 weeks after first use of digital therapeutics
Orthostatic BP will be recorded during the Run-in period (2 wks) and the Intervetion period (6 wks). The orthostatic BP drops are expected to decrease in the treatment group than in the sham control group.
For 8 weeks after first use of digital therapeutics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2025-0056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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