Transcutaneous Electrical Acustimulation in Automatic Synchronization With Breathing for Treating Functional Dyspepsia: A Phase I Feasibility Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Determine the device safety when self-administered at home by patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 and older
- •Must meet Rome IV criteria for functional dyspepsia
排除标准
- •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.
研究组 & 干预措施
Adult patients with functional dyspepsia
The treatment this arm will be administered is the AutoSTEA treatment, which consists of a band-like device that wraps around the rib cage. This device is connected to a microstimulator which is then connected to TENS pads. The band allows for the electrical impulses given to be synchronized with one's breathing.
干预措施: Transcutaneous electrical acustimulation in automatic synchronization with breathing (Device)
结局指标
主要结局
Determine the device safety when self-administered at home by patients
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Assess a diverse participant pool, especially overweight/obese female patients(From enrollment to the end of treatment in two weeks)
- Assess patient's compliance to AutoSTEA treatment(From enrollment to the end of treatment in two weeks)