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New treatment option for GERD
Official title Diaphragmatic Training on GERD
ClinicalTrials.gov ID: NCT07544433
What this study is testing
- What it's testing
- he goal of this clinical trial is to evaluate the effects of diaphragm-oriented breathing training on patients with gastroesophageal reflux disease (GERD). This study will compare two non-invasive respiratory interventions-diaphragmatic breathing exercise (DBE) and volume-oriented incentive spirometry (VIS)-in terms of their impact on esophageal function and health-related quality of life.The main questions it aims to answer are:Does DBE or VIS improve GERD symptoms as measured by the GERD Questionnaire (GERDQ)?Do these interventions reduce esophageal acid exposure time and the number of reflux episodes?Do these interventions improve lower esophageal sphincter (LES) pressure and esophageal motility?Do these interventions improve GERD-related quality of life as measured by the GERD-HRQL questionnaire?Researchers will compare three groups: DBE, VIS, and a control group receiving standard care, to determine whether diaphragm-oriented breathing training provides additional benefits over usual management.Participants will:Be randomly assigned to one of three groups (DBE, VIS, or control)Perform the assigned intervention for 6 weeksUndergo baseline and post-intervention assessments, including symptom questionnaires and esophageal function testing Record symptoms and adherence in a daily diary
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 80
You may be able to join if
- Include Criteria:
- Age between 20 and 80 years.2. A confirmed diagnosis of gastroesophageal reflux disease (GERD), defined by at least one of the following criteria
- Endoscopic examination within the past 3 months demonstrating Los Angeles (LA) grade A reflux esophagitis with regular use of acid-suppressive...
- 24-hour esophageal pH monitoring showing acid exposure time (AET) \> 6%.
- Endoscopic examination within the past 3 months demonstrating LA grade B or higher reflux esophagitis.
You likely can't join if
- Pregnant or breastfeeding women.
- History of anti-reflux surgery or other upper gastrointestinal surgical procedures related to GERD.
- Presence of significant cardiopulmonary disease or chronic respiratory disease that may compromise the safety or feasibility of performing breathing...
- Inability to comply with the study protocol, including participation in training procedures and scheduled follow-up visits, due to conditions such as...
See the full eligibility criteria
- Include Criteria:
- Age between 20 and 80 years.2. A confirmed diagnosis of gastroesophageal reflux disease (GERD), defined by at least one of the following criteria
- Endoscopic examination within the past 3 months demonstrating Los Angeles (LA) grade A reflux esophagitis with regular use of acid-suppressive medication (e.g., proton pump inhibitors) for more than 2 months.
- 24-hour esophageal pH monitoring showing acid exposure time (AET) \> 6%.
- Endoscopic examination within the past 3 months demonstrating LA grade B or higher reflux esophagitis.
- Willingness and ability to participate in the intervention program, including adherence to training protocols, scheduled follow-up visits, and completion of all required assessments during the study period.
- Pregnant or breastfeeding women.
- History of anti-reflux surgery or other upper gastrointestinal surgical procedures related to GERD.
- Presence of significant cardiopulmonary disease or chronic respiratory disease that may compromise the safety or feasibility of performing breathing training.
- Inability to comply with the study protocol, including participation in training procedures and scheduled follow-up visits, due to conditions such as cognitive impairment, physical limitations, or inability to attend...
The study team makes the final eligibility decision.
Where it's taking place
- Changhua, Changhua County, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changhua, Changhua County, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.