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

NCT06685900 | Completed

• 1 other identifier: 1-2024-0028
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• The number of hypotension symptom events

  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.

  within the first 6weeks after intervention

Secondary Outcomes (4)

• 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

Study Arms (2)

Early intervention group (EIG)

EXPERIMENTAL

the trial group that begins treatment in the 3-week of the total 15-week study period

Device: digital therapeutics

Late intervention group (LIG)

EXPERIMENTAL

the comparator group that begins treament in the 9-week of the total 15-week study period

Device: digital therapeutics

Interventions

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.

Early intervention group (EIG)

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei university college of medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant and Sub-investigator
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: November 13, 2024
• Study Start: November 11, 2024
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

KR (1)