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NCT Number: NCT07020416

AutoSTEA for Adults With Functional Dyspepsia

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Functional Dyspepsia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MetroHealth Medical Center - Main Campus, Cleveland, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous electrical acustimulation in automatic synchronization with breathing

Device

This intervention will be carried out via the AutoSTEA device.

Primary outcomes

  1. Determine the device safety when self-administered at home by patients

    Time frame: From enrollment to the end of treatment in two 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 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 the least severe and 5 being the most severe.

  2. Evaluate device usability

    Time frame: From enrollment to the end of treatment in two 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 (with 0 being the worst and 5 being the best) how easy and comfortable the device was for them.

  3. Assess symptom responses to treatment

    Time frame: From enrollment to the end of treatment in two weeks

    Assess how well a patient's dyspepsia symptoms respond to the treatment. This will be done via two questionnaires. 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 5 being extreme effect on their daily lives. The second 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.

Secondary outcomes

  1. Assess a diverse participant pool, especially overweight/obese female patients

    Time frame: From enrollment to the end of treatment in two weeks

    Assess the response that patients have with a focus on those who are overweight/obese and female. This will be analyzed via the two dyspepsia symptom questionnaires that are mentioned in outcome 3.

  2. Assess patient's compliance to AutoSTEA treatment

    Time frame: From enrollment to the end of treatment in two weeks

    Assess if patients followed through with the required usage of the device and treatment. This will be done via their own self-reporting to study staff of if they missed any treatment days.

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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