An interventional study of Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise and standard pharmacological treatment with lifestyle modification education in Functional Heartburn (FH) and Reflux Hypersensitivity, sponsored by Changhua Christian Hospital. Not yet recruiting. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Changhua Christian Hospital · Not applicable, Interventional, and Supportive care
The goal of this pilot randomized controlled trial is to determine whether volume-oriented incentive spirometry-assisted diaphragmatic breathing exercise (VIS-assisted DBE) can improve reflux-related symptoms and health-related quality of life in adults with functional heartburn (FH) or reflux hypersensitivity (RH).
The main questions it aims to answer are:
Does VIS-assisted DBE reduce reflux-related symptoms compared with usual care? Does VIS-assisted DBE improve health-related quality of life compared with usual care? Researchers will compare VIS-assisted DBE plus usual care with usual care alone to determine whether the intervention provides additional benefits in symptom relief and quality of life.
Participants will:
Complete baseline clinical evaluations and symptom questionnaires. Be randomly assigned to either the VIS-assisted DBE group or the usual care group.
Receive either VIS-assisted diaphragmatic breathing exercises twice daily for 20 minutes over a 4-week period in addition to usual care, or usual care alone.
Complete follow-up assessments after the 4-week intervention, including symptom and quality-of-life questionnaires
Functional heartburn (FH) and reflux hypersensitivity (RH) are disorders of gut-brain interaction characterized by persistent reflux-related symptoms despite the absence of significant esophageal acid exposure or structural abnormalities. Although proton pump inhibitors are widely used for reflux-related disorders, many patients with FH and RH continue to experience persistent symptoms, resulting in reduced health-related quality of life. Current evidence suggests that altered esophageal sensory processing, autonomic nervous system dysfunction, and impaired gut-brain axis regulation contribute to symptom generation in these disorders.
Diaphragmatic breathing exercise has emerged as a promising non-pharmacological intervention that may improve diaphragmatic function, enhance vagal activity, and reduce reflux-related symptoms. Volume-oriented incentive spirometry (VIS) provides visual feedback during breathing training and may improve the consistency and effectiveness of diaphragmatic breathing. However, evidence regarding the therapeutic effects of VIS-assisted diaphragmatic breathing exercise in patients with FH or RH remains limited.
This prospective, parallel-group, pilot randomized controlled trial is designed to evaluate the clinical effectiveness of VIS-assisted diaphragmatic breathing exercise in adults with FH or RH. Participants will be randomly assigned to receive either VIS-assisted diaphragmatic breathing exercise in addition to usual care or usual care alone. The study will assess whether the intervention improves reflux-related symptoms and health-related quality of life compared with usual care.
The findings of this study are expected to provide preliminary evidence regarding the feasibility and potential clinical benefits of VIS-assisted diaphragmatic breathing exercise as an adjunctive non-pharmacological treatment for functional heartburn and reflux hypersensitivity, and to support the design of future larger randomized controlled trials.
154 studies on the registry are indexed under Heartburn; 12 are open to participants now.
This study's planned enrollment of 82 is below the median of 100 across 127 interventional studies indexed under Heartburn.
Browse Heartburn studies →Changhua Christian Hospital is the lead sponsor of 76 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults aged 20 to 100 years.
Pregnant or breastfeeding women.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will perform diaphragmatic breathing exercises assisted by a volume-oriented incentive spirometer twice daily for 20 minutes per session over a 4-week intervention period under standardized instructions.
Behavioral: Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise
Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise.
Behavioral: standard pharmacological treatment with lifestyle modification education
Participants will perform diaphragmatic breathing exercises assisted by a volume-oriented incentive spirometer twice daily for 20 minutes per session over a 4-week intervention period under standardized instructions.
Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise.
Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score
The primary outcome is the change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) score from baseline to the end of the 4-week intervention. The GERDQ is a validated patient-reported questionnaire used to assess the frequency and severity of reflux-related symptoms. Higher scores indicate more severe symptoms. The change in GERDQ score will be compared between the intervention and usual care groups
Time frame: From baseline to Week 4
Change in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Score
The secondary outcome is the change in the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) score from baseline to the end of the 4-week intervention. The GERD-HRQL questionnaire evaluates the impact of reflux-related symptoms on health-related quality of life. Higher scores indicate poorer health-related quality of life. The change in GERD-HRQL score will be compared between the intervention and usual care groups
Time frame: From baseline to Week 4
Change in Reflux Disease Questionnaire (RDQ) Score
The secondary outcome is the change in the Reflux Disease Questionnaire (RDQ) score from baseline to the end of the 4-week intervention. The RDQ is a validated patient-reported questionnaire that assesses the frequency and severity of reflux-related symptoms. Higher scores indicate more severe symptoms. The change in RDQ score will be compared between the intervention and usual care groups.
Time frame: From baseline to Week 4
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Apr 2028, 20 months later.
Of 26 interventional studies with no phase under Heartburn, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 20 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Changhua Christian Hospital