HypotensionNCT07348445
Clinical Trial of Digital Therapeutics (One.Dr) for Suspected Orthostatic Hypotension Patients
A study testing Digital therapeutics (One.Dr Application) in people with Hypotension and Orthostasis, run by Yonsei University.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypotension, Orthostasis
- What is being tested?
- Digital therapeutics (One.Dr Application)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Digital therapeutics (One.Dr Application), Digital therapeutics (Sham Application)
- Medical subject headings
- Hypotension, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Digital therapeutics (Sham Application)Other
An application that provides general health knowledge via a smart device
| Study group | Role | What they receive |
|---|---|---|
| One.Dr Application | Experimental | Not described Receives: Other: Digital therapeutics (One.Dr Application) |
| Sham Application | Sham comparator | Not described Receives: Other: Digital therapeutics (Sham Application) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For 8 weeks after first use of digital therapeutics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348445
- Sponsor's protocol ID
- 1-2025-0056
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07348445
- Acronym / sponsor ID
- 1-2025-0056
- Conditions
- Hypotension, Orthostasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One.Dr Application | Experimental | Other: Digital therapeutics (One.Dr Application) |
| Sham Application | Sham comparator | Other: Digital therapeutics (Sham Application) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | One.Dr Application |
| Digital therapeutics (Sham Application)An application that provides general health knowledge via a smart device | Other | Sham Application |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Digital therapeutics (One.Dr Application) in people with Hypotension and Orthostasis, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-Sun Kim, MD (02-2228-8457, kjs1218@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.