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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07348445

Enrollment

Registered

2026-01-16

Start date

2026-01-01

Completion date

2026-04-01

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Orthostasis

Brief 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.

Interventions

OTHERDigital therapeutics (One.Dr Application)

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

OTHERDigital therapeutics (Sham Application)

An application that provides general health knowledge via a smart device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
The changes in orthostatic SBP or DBP drop between the Run-in period and the Intervetion period	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.

Contacts

CONTACTJung-Sun Kim, MD

kjs1218@yuhs.ac02-2228-8457

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026