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

NCT ID: NCT07348445

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

One.Dr Application

Group Type: EXPERIMENTAL

Digital therapeutics (One.Dr Application)

Intervention Type: OTHER

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

Sham Application

Group Type: SHAM_COMPARATOR

Digital therapeutics (Sham Application)

Intervention Type: OTHER

An application that provides general health knowledge via a smart device

Interventions

Digital therapeutics (One.Dr Application)

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

Intervention Type: OTHER

Digital therapeutics (Sham Application)

An application that provides general health knowledge via a smart device

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jung-Sun Kim, MD

Role: CONTACT

kjs1218@yuhs.ac

02-2228-8457

Other Identifiers

1-2025-0056

Identifier Type: -

Identifier Source: org_study_id