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

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Dizziness Neurologic Manifestations Orthostasis Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Digital therapeutics (One.Dr Application)

Other

An application that provides educations and non-pharmaceutical treatment (participant customized content) for orthostatic hypotension via a smart device

Digital therapeutics (Sham Application)

Other

An application that provides general health knowledge via a smart device

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jung-Sun Kim, MD

CONTACT

[email protected]

02-2228-8457

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jan 16, 2026
Registry last updated: Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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