Functional Heartburn (FH)VISDBENCT07706101
Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise for Functional Heartburn or Reflux Hypersensitivity
A study testing Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise and standard pharmacological treatment with lifestyle modification education in people with Functional Heartburn (FH) and Reflux Hypersensitivity, run by Changhua Christian Hospital.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Functional Heartburn (FH), Reflux Hypersensitivity
- What is being tested?
- Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise and standard pharmacological treatment with lifestyle modification education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 to 100 years.
- Diagnosis of functional heartburn (FH) or reflux hypersensitivity (RH) according to the Rome IV criteria.
- Normal upper gastrointestinal endoscopy without evidence of erosive esophagitis, Barrett's esophagus, or hiatal hernia.
- Normal esophageal motility on high-resolution manometry (HRM) according to the Chicago Classification Version 4.0.
- Diagnosis of FH or RH confirmed by 24-hour multichannel intraluminal impedance-pH (MII-pH) monitoring according to the Rome IV criteria and Lyon Consensus 2.0.
- Able and willing to perform diaphragmatic breathing exercises and comply with study procedures.
- Able to provide written informed consent.
Who cannot join
- Pregnant or breastfeeding women.
- Severe cardiopulmonary dysfunction or chronic respiratory disease.
- Inability to perform diaphragmatic breathing exercises or comply with the study protocol and scheduled follow-up visits
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise in Patients With Functional Heartburn or Reflux Hypersensitivity: A Pilot Randomized Controlled Trial
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:
Read more
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
Read the detailed description
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.
- Conditions
- Functional Heartburn (FH), Reflux Hypersensitivity
- Being tested
- Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise, standard pharmacological treatment with lifestyle modification education
- Keywords
- Functional Heartburn, Reflux Hypersensitivity, Volume-Oriented Incentive Spirometry, Diaphragmatic Breathing Exercise, Disorders of Gut-Brain Interaction, Autonomic Nervous System, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing ExerciseBehavioural
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.
standard pharmacological treatment with lifestyle modification educationBehavioural
Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise.
| Study group | Role | What they receive |
|---|---|---|
| Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise Group (VIS) | Experimental | 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. Receives: Behavioral: Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise |
| Usual Care | Active comparator | Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise. Receives: Behavioral: standard pharmacological treatment with lifestyle modification education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to Week 4
Secondary outcomes (2)
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
Measured: 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.
Measured: From baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start20 Aug 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Heartburn (FH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel study arms using block randomization.
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun-Ching Chou, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706101
- Sponsor's protocol ID
- CCH-IRB-260526
- Acronym
- VISDBE
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise in Patients With Functional Heartburn or Reflux Hypersensitivity: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07706101
- Acronym / sponsor ID
- VISDBE / CCH-IRB-260526
- Conditions
- Functional Heartburn (FH), Reflux Hypersensitivity
- Keywords
- Functional Heartburn, Reflux Hypersensitivity, Volume-Oriented Incentive Spirometry, Diaphragmatic Breathing Exercise, Disorders of Gut-Brain Interaction, Autonomic Nervous System, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel study arms using block randomization.
| Arm | Type | Receives |
|---|---|---|
| Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise Group (VIS) | Experimental | Behavioral: Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing ExerciseParticipants 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. |
| Usual Care | Active comparator | Behavioral: standard pharmacological treatment with lifestyle modification educationParticipants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing ExerciseParticipants 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. | Behavioural | Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise Group (VIS) |
| standard pharmacological treatment with lifestyle modification educationParticipants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise. | Behavioural | Usual Care |
Primary outcome
Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score
Time frame: From baseline to Week 4
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
2 secondary outcomes
Change in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Score
Time frame: From baseline to Week 4
Change in Reflux Disease Questionnaire (RDQ) Score
Time frame: From baseline to Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise and standard pharmacological treatment with lifestyle modification education in people with Functional Heartburn (FH) and Reflux Hypersensitivity, run by Changhua Christian Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shu-Ju Tu, NP, PHD Candidate (+88647238595 ext. 7591, 79610@cch.orh.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score (time frame: From baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.