NCT06685900

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypotension

Interventions

Type	Name	Description
DEVICE	digital therapeutics	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.
DEVICE	digital therapeutics	Late intervention group will undergo app usage training, disease education, blood pressure measurements, orthostatic blood pressure measurements, and postprandial blood pressure measurements up to the ninth week of participation. From the tenth week onward, for a duration of 6 weeks, non-pharmacological treatment education will be provided through a digital therapeutic, and blood pressure will be measured according to a specified schedule.

Timeline

• Start date: 2024-11-11
• Primary completion: 2025-04-21
• Completion: 2025-04-21
• First posted: 2024-11-13
• Last updated: 2025-08-24

Locations

1 site across 1 country: South Korea