Clinical Trial of Digital Therapeutics (One.Dr) for Suspected Orthostatic Hypotension Patients (NCT07348445) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Trial of Digital Therapeutics (One.Dr) for Suspected Orthostatic Hypotension Patients
86 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The changes in orthostatic SBP or DBP drop between the Run-in period and the Intervetion period
Timeframe: For 8 weeks after first use of digital therapeutics
. 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)