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Completed

NCT Number: NCT06685900

Efficacy and Safety of Symptom Improvement by Digital Therapeutics to Manage Hypotension Symptoms

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

19 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei university college of medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Digital Therapeutics

Device

Early intervention group will undergo app usage training, disease education, blood pressure measurements, orthostatic blood pressure measurements, and postprandial blood pressure measurements up to the third week of participation. From the fourth week onward, for a duration of 12 weeks, non-pharmacological treatment education will be provided through a digital therapeutic, and blood pressure will be measured according to a specified schedule.

Primary outcomes

  1. 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

  1. Number of symptoms related to hypotension

    Time frame: over 15weeks

    Comparison of the frequency of symptoms suspected to be caused by hypotension before and after the intervention

  2. Number of falling accident

    Time frame: over 15weeks

    To investigate whether regularly measuring blood pressure can help prevent falls.

  3. Details for disease diagnosis and concomitant medications

    Time frame: over 15weeks

    To idenfity the correlation between hypotension and other causes and symptoms

  4. The frequency of use of digital therapeutics

    Time frame: at 15weeks

    To identify how many times participants use digital therapeutics to measure blood pressure.

    Display the frequency of data input through digital therapeutics as the mean or median.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

A Single-center, Randomized Controlled Pilot Trial to Evaluate Efficacy and Safety of Symptom Improvement by Digital Therapeutics to Manage Hypotension Symptoms

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2024
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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