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

NCT07348445 | Not Yet Recruiting

• 1 other identifier: 1-2025-0056
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypotension; Orthostasis

Outcome Measures

Primary Outcomes (1)

• The changes in orthostatic SBP or DBP drop between the Run-in period and the Intervetion period

  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

Study Arms (2)

One.Dr Application

EXPERIMENTAL

Other: Digital therapeutics (One.Dr Application)

Sham Application

SHAM COMPARATOR

Other: Digital therapeutics (Sham Application)

Interventions

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

One.Dr Application

Digital therapeutics (Sham Application) OTHER

An application that provides general health knowledge via a smart device

Sham Application

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Hypotension; Dizziness

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jung-Sun Kim, MD

CONTACT

02-2228-8457; kjs1218@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01