AutoSTEA for Adults With Functional Dyspepsia

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

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.

Inclusion Criteria:

• 18 and older
• Must meet Rome IV criteria for functional dyspepsia

Exclusion Criteria:

• Patients with dyspepsia symptoms that have been fully resolved by antisecretory, antidepressant, or prokinetic therapy
• History of active NSAID use, unhealed esophagitis, unhealed ulcer disease, or other GI diseases that can explain their dyspepsia symptoms.
• History of upper GI surgeries and upper GI cancers, uncontrolled diabetes (type 1 and 2), severe psychiatric conditions, uncontrolled medical disorders, total knee replacement surgery, or above-the-knee amputation.
• Patients with H. pylori infection without confirmed eradication will also be excluded.