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

Yonsei University

Status: Completed

Conditions: Hypotension

Treatments: Device: digital therapeutics

Study type: Interventional

Funder types: Other

Identifiers

NCT06685900

1-2024-0028

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 19 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

8 participants in 2 patient groups

Early intervention group (EIG)

Experimental group

Description:

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

Treatment:

Device: digital therapeutics

Device: digital therapeutics

Late intervention group (LIG)

Experimental group

Description:

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

Treatment:

Device: digital therapeutics

Device: digital therapeutics