Clinical Trial of Digital Therapeutics (One.Dr) for Suspected Orthostatic Hypotension Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Digital therapeutics (One.Dr Application)
Other interventionAn application that provides educations and non-pharmaceutical treatment (participant customized content) for orthostatic hypotension via a smart device
Digital therapeutics (Sham Application)
Other interventionAn application that provides general health knowledge via a smart device
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: One.Dr ApplicationExperimental treatment 1 intervention
Group B: Sham ApplicationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
For 8 weeks after first use of digital therapeuticsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: