TEA Synchronized With Natural Breathing for EPS

October 30, 2026 updated by: MetroHealth Medical Center

Transcutaneous Electrical Acustimulation Synchronized With Natural Breathing for Epigastric Pain Syndrome

The goal of this study is to assess the acceptance and usability as well as safety of the AutoSTEA device is in treating epigastric pain syndrome in adults. It will also explore preliminary clinical and mechanistic signals. The main questions it aims to answer are:

  • Does the AutoSTEA device ease epigastric pain symptoms?
  • Is the AutoSTEA device safe and feasible for patients to use at their home?

Participants will:

  • Use the device for 30-60 minutes at home each day for 4 weeks
  • Have a phone check-in four times through the trial (once a week).
  • Answer the daily and weekly questionnaires which consist of questions regarding symptoms, device usability, and adverse events experienced.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
      • Parma, Ohio, United States, 44130
        • MetroHealth Parma Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years of age
  • Diagnosed with epigastric pain syndrome according to Rome V Criteria
  • Experienced epigastric pain at least 3 days a week for at least 3 months
  • Must have normal esophagogastroduodenoscopy performed in last 2 years

Exclusion Criteria:

  • Any history of gastritis, gastric/duodenal ulcers, or other organic upper GI diseases
  • Current drug or alcohol abuse
  • Currently pregnant or planning to become pregnant
  • History of major abdominal surgery
  • History of severe mental illness
  • Total knee-replacement surgery or above-the-knee amputation
  • Any unstable or uncontrolled medical disorders
  • Current use of proton pump inhibitors, anti-nausea medications, or other functional dyspepsia treatments UNLESS regimen has remained unchanged and stable over last 3 months
  • Current use of anti-depressants or NSAIDs
  • Having any implanted electrical devices (pacemakers, defibrillators, neurostimulators, or any other implanted electrical devices).
  • Not being fluent in English
  • Having prior significant experience/knowledge with acupuncture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment First Arm

This arm will receive the experimental treatment for 4 weeks.
Device: AutoSTEA device

The AutoSTEA device is a device that detects the user's respiration wave and synchronizes each breath to deliver electrical stimulation at acupuncture points via skin surface electrodes. With this automated synchronization device, patients can inhale and exhale with an uninterrupted and normal respiration pace while receiving the TEA treatment, largely simplifying the treatment procedures, improving patients' compliance, and enhancing the effectiveness of the method.
Other: Sham first arm

This arm will first receive the sham treatment for 4 weeks.
Device: Sham treatment

The sham treatment is the same as the AutoSTEA device except that it doesn't synchronize with users breathing. It still does deliver the same electric shocks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's Symptom Response to the Treatment as Assessed by Functional Dyspepsia Symptom Diary
Time Frame: From enrollment to the end of treatment in four weeks

This questionnaire will be filled out daily, and it describes the physical dyspepsia symptoms experienced by the patient in the last 24 hours. It is done on a scale from 0-10, with 0 meaning they have not experienced a symptom at all, and 10 being they have severely experienced a symptom.
From enrollment to the end of treatment in four weeks
Patient's Symptom Response to the Treatment as Assessed by Nepean Dyspepsia Index Questionnaire
Time Frame: From enrollment until the end of treatment at 4 weeks

Assess how well a patient's dyspepsia symptoms respond to the treatment. This will be done using the Nepean Dyspepsia Index Questionnaire. One will be filled out weekly, where patients describe how much their dyspepsia symptoms have affected their daily lives. The scale for this will be 0-4, with 0 being no effect on their daily life and 4 being extreme effect on their daily lives.
From enrollment until the end of treatment at 4 weeks
Patient's Operating Experience with the Device as Assessed by Usability and Comfort Questionnaire
Time Frame: From enrollment to the end of treatment in four weeks

Assess how easy the device is for patients to use in their home. This will be done using the usability questionnaire. This questionnaire will be filled out daily and the user will rate on a 0-5 scale how easy and comfortable the device was to use. 0 would signify the device being extremely difficult and extremely uncomfortable to use, while 5 would signify the device being extremely easy and extremely comfortable to use.
From enrollment to the end of treatment in four weeks
Patient's Operating Experience with the Device when Self-Administered at Home as Assessed by the Weekly Safety and Adverse Events Questionnaire
Time Frame: From enrollment to the end of treatment in four weeks

Assess any adverse effects the device may have when used by patients in their home. This will be done using the device safety questionnaire. The safety questionnaire is to be filled out weekly, with any adverse event that is experienced being reported. These adverse events (if applicable) will be rated in severity on a 0-5 scale, with 0 being no experienced adverse event and 5 being extremely severe (requiring medical attention).
From enrollment to the end of treatment in four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Patient Compliance with Device as Assessed by Daily Device-Use Log
Time Frame: From enrollment to the end of treatment in four weeks

Patients will keep a device-use log that is filled out daily. They will write how many sessions they use the device for and how long each session was.
From enrollment to the end of treatment in four weeks
Electrogastrogram (EGG) Measure
Time Frame: Once during the initial visit and once during the final visit (weeks 0 and 4).

The patient will undergo an EGG. The myoelectrical activity of the stomach will be measured by cycles per minute (CPM), which is the frequency of electrical slow waves generated by the smooth muscles of the stomach. A CPM of under 2.5 or above 3.75 will be considered abnormal.
Once during the initial visit and once during the final visit (weeks 0 and 4).
Electrocardiogram (ECG) Measure
Time Frame: Once during the initial visit and once during the final visit (weeks 0 and 4).

Patients will undergo an ECG. This will measure their heart rate variability (HRV) by tracking the interval in milliseconds between each heartbeat. What is considered normal or abnormal will vary greatly depending on the patient.
Once during the initial visit and once during the final visit (weeks 0 and 4).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

August 25, 2026

First Submitted That Met QC Criteria

October 30, 2026

First Posted (Actual)

November 4, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

October 30, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00000910

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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