NCT07020416

AutoSTEA for Adults With Functional Dyspepsia

Transcutaneous Electrical Acustimulation in Automatic Synchronization With Breathing for Treating Functional Dyspepsia: A Phase I Feasibility Trial

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DEVICE	Transcutaneous electrical acustimulation in automatic synchronization with breathing	This intervention will be carried out via the AutoSTEA device.

Timeline

• Start date: 2025-02-26
• Primary completion: 2026-04-01
• Completion: 2027-02-01
• First posted: 2025-06-13
• Last updated: 2025-06-13

Locations

2 sites across 1 country: United States