Clinical Trial of Digital Therapeutics (One.Dr) for Suspected Orthostatic Hypotension Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital therapeutics (One.Dr Application), Digital therapeutics (Sham Application).
- Who it may be relevant to
- Registry conditions: Hypotension, Orthostasis. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Other Digital therapeutics (One.Dr Application)
An application that provides educations and non-pharmaceutical treatment (participant customized content) for orthostatic hypotension via a smart device - Other Digital therapeutics (Sham Application)
An application that provides general health knowledge via a smart device
Primary outcome measures
- 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]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07348445 · 1-2025-0056