Functional Dyspepsia
Conditions
Brief 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.
Interventions
DEVICETranscutaneous electrical acustimulation in automatic synchronization with breathing
This intervention will be carried out via the AutoSTEA device.
Sponsors
MetroHealth Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the device safety when self-administered at home by patients | 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. |
| Evaluate device usability | 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. |
| Assess symptom responses to treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Assess a diverse participant pool, especially overweight/obese female patients | 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. |
| Assess patient's compliance to AutoSTEA treatment | 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. |
Countries
United States
Outcome results
None listed