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

Yonsei University

Status: Not yet enrolling

Conditions: Orthostasis; Hypotension

Treatments: Other: Digital therapeutics (Sham Application); Other: Digital therapeutics (One.Dr Application)

Study type: Interventional

Funder types: Other

Identifiers

NCT07348445

1-2025-0056

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

One.Dr Application

Experimental group

Treatment:

Other: Digital therapeutics (One.Dr Application)

Sham Application

Sham Comparator group

Treatment:

Other: Digital therapeutics (Sham Application)