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

Not Applicable

Not yet recruiting

• Conditions: Hypotension

• Registration Number: NCT06685900
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-06
• Status Verified: 2024-11
• Study Start: 2024-11
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study First Posted: 2024-11-13
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-03-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Adults aged 19 and older with symptoms suspected to be related to dizziness due to hypotension within the past year.
2. 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

1. Individuals diagnosed with causes of dizziness other than hypotension, such as benign paroxysmal positional vertigo or stroke, within the past year.
2. Severe anemia (history of Hb < 8.0 g/dL within the last 3 months).
3. Individuals unable to use a smartphone (Android phone) or smartwatch.
4. Individuals with a life expectancy of less than 1 year due to diseases such as malignant tumors.
5. Individuals diagnosed with severe heart valve disease or severe heart failure with LVEF < 35% (based on the most recent examination).
6. Recent rapid and unintended weight loss (5% or more, or 5 kg or more, within the last 6 months).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The number of hypotension symptom events	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 Outcome Measures

Name	Time	Method
Number of symptoms related to hypotension	over 15weeks	Comparison of the frequency of symptoms suspected to be caused by hypotension before and after the intervention
Number of falling accident	over 15weeks	To investigate whether regularly measuring blood pressure can help prevent falls.
Details for disease diagnosis and concomitant medications	over 15weeks	To idenfity the correlation between hypotension and other causes and symptoms
The frequency of use of digital therapeutics	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.

Trial Locations

Locations (1)

Yonsei university college of medicine; 🇰🇷 Seoul, Korea, Republic of