TEA Synchronized With Natural Breathing for EPS
NCT07917598, Phase 1, Not yet recruiting, MetroHealth Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | TEA Synchronized With Natural Breathing for EPS | ClinicalTrials.gov |
| NCT number | NCT07917598 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | MetroHealth Medical Center | ClinicalTrials.gov |
| Conditions | Epigastric Pain Syndrome | ClinicalTrials.gov |
| Interventions | AutoSTEA device, Sham treatment | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Patient's Symptom Response to the Treatment as Assessed by Functional Dyspepsia Symptom Diary | 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. | ClinicalTrials.gov |
| Primary | Patient's Symptom Response to the Treatment as Assessed by Nepean Dyspepsia Index Questionnaire | 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. | ClinicalTrials.gov |
| Primary | Patient's Operating Experience with the Device as Assessed by Usability and Comfort Questionnaire | 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. | ClinicalTrials.gov |
| Primary | Patient's Operating Experience with the Device when Self-Administered at Home as Assessed by the Weekly Safety and Adverse Events Questionnaire | 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). | ClinicalTrials.gov |
| Secondary | Assess Patient Compliance with Device as Assessed by Daily Device-Use Log | 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. | ClinicalTrials.gov |
| Secondary | Electrogastrogram (EGG) Measure | 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. | ClinicalTrials.gov |
| Secondary | Electrocardiogram (ECG) Measure | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)