A Single-center, Randomized Controlled Pilot Trial to Evaluate Efficacy and Safety of Symptom Improvement by Digital Therapeutics to Manage Hypotension Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- The number of hypotension symptom events
Study Overview
Brief Summary
This clinical trial is an exploratory study aimed at assessing the efficacy and safety of a digital therapeutic for managing symptoms of hypotension, with the goal of providing evidence for the design of future confirmatory clinical research.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Investigator)
Masking Description
Participant and Sub-investigator
Eligibility Criteria
- Ages
- 19 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 19 and older with symptoms suspected to be related to dizziness due to hypotension within the past year.
- •Individuals who are able to walk and can participate in the study using a smartphone, or for whom cooperation from a guardian is available.
Exclusion Criteria
- •Individuals diagnosed with causes of dizziness other than hypotension, such as benign paroxysmal positional vertigo or stroke, within the past year.
- •Severe anemia (history of Hb < 8.0 g/dL within the last 3 months).
- •Individuals unable to use a smartphone (Android phone) or smartwatch.
- •Individuals with a life expectancy of less than 1 year due to diseases such as malignant tumors.
- •Individuals diagnosed with severe heart valve disease or severe heart failure with LVEF < 35% (based on the most recent examination).
- •Recent rapid and unintended weight loss (5% or more, or 5 kg or more, within the last 6 months).
Arms & Interventions
Early intervention group (EIG)
the trial group that begins treatment in the 3-week of the total 15-week study period
Intervention: digital therapeutics (Device)
Late intervention group (LIG)
the comparator group that begins treament in the 9-week of the total 15-week study period
Intervention: digital therapeutics (Device)
Outcomes
Primary Outcomes
The number of hypotension symptom events
Time Frame: within the first 6weeks after intervention
The effectiveness of symptom improvement for hypotension was evaluated in the trial and control groups based on the frequency of hypotension symptoms over a 6-week period.
Secondary Outcomes
- Number of symptoms related to hypotension(over 15weeks)
- Number of falling accident(over 15weeks)
- Details for disease diagnosis and concomitant medications(over 15weeks)
- The frequency of use of digital therapeutics(at 15weeks)