TEA Synchronized With Natural Breathing for EPS
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Donovan Veccia
- Numéro de téléphone: 2167783567
- E-mail: dveccia@metrohealth.org
Lieux d'étude
-
-
Ohio
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Cleveland, Ohio, États-Unis, 44109
- MetroHealth Medical Center
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Contact:
- Donovan Veccia
- Numéro de téléphone: 216-924-6246
- E-mail: dveccia@metrohealth.org
-
Parma, Ohio, États-Unis, 44130
- MetroHealth Parma Medical Center
-
Contact:
- Donovan Veccia
- Numéro de téléphone: 216-924-6246
- E-mail: dveccia@metrohealth.org
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Treatment First Arm
This arm will receive the experimental treatment for 4 weeks. |
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. |
|
Autre: Sham first arm
This arm will first receive the sham treatment for 4 weeks. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient's Symptom Response to the Treatment as Assessed by Functional Dyspepsia Symptom Diary
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Assess Patient Compliance with Device as Assessed by Daily Device-Use Log
Délai: 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
Délai: 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
Délai: 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).
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- STUDY00000910
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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