Transcutaneous Electrical Acustimulation in Automatic Synchronization With Breathing for Treating Functional Dyspepsia: A Phase I Feasibility Trial
Active, Not Recruiting Phase 1 NCT07020416
Study Description
The goal of this study is to assess how effective the AutoSTEA device is in treating functional dyspepsia (upper abdominal discomfort) in adults. It will also assess the safety and usability of the device. The main questions it aims to answer are: * Does the AutoSTEA device ease dyspepsia symptoms? * Is the AutoSTEA device safe and feasible for patients to use at their home? Participants will: * Use the device for half an hour every day for two weeks * Have a phone check-in halfway through the trial * Answer the daily and weekly questionnaires which consist of questions regarding symptoms, device usability, and adverse events experienced.
Study Details
- Registry ID:
- NCT07020416
- Conditions:
- Functional Dyspepsia
- Phase:
- Phase 1
- Target Enrollment:
- 20 participants
- Start Date:
- Age Range:
- 18–999 years
- Healthy Volunteers:
- No
Study Locations (2 sites)
-
MetroHealth Parma Medical Center
Parma, Ohio, United States -
MetroHealth Medical Center - Main Campus
Cleveland, Ohio, United States
Interested in Participating?
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