[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"functional-heartburn-fh\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:functional-heartburn-fh":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100647198","volume-oriented-incentive-spirometry-assisted-diaphragmatic-breathing-exercise-for-functional-heartburn-or-reflux-hypersensitivity-100647198",false,"NCT07706101","Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise for Functional Heartburn or Reflux Hypersensitivity","Effect of Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise in Patients With Functional Heartburn or Reflux Hypersensitivity: A Pilot Randomized Controlled Trial","VISDBE","* Inclusion Criteria:\n\n  * Adults aged 20 to 100 years.\n  * Diagnosis of functional heartburn (FH) or reflux hypersensitivity (RH) according to the Rome IV criteria.\n  * Normal upper gastrointestinal endoscopy without evidence of erosive esophagitis, Barrett's esophagus, or hiatal hernia.\n  * Normal esophageal motility on high-resolution manometry (HRM) according to the Chicago Classification Version 4.0.\n  * 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.\n  * Able and willing to perform diaphragmatic breathing exercises and comply with study procedures.\n  * Able to provide written informed consent.\n* Exclusion Criteria:\n\n  * Pregnant or breastfeeding women.\n  * Severe cardiopulmonary dysfunction or chronic respiratory disease.\n  * Inability to perform diaphragmatic breathing exercises or comply with the study protocol and scheduled follow-up visits","ALL","20 Years","100 Years",{"count":21,"type":22},82,"ESTIMATED","INTERVENTIONAL",[25],"NA","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).\n\nThe main questions it aims to answer are:\n\nDoes 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.\n\nParticipants will:\n\nComplete baseline clinical evaluations and symptom questionnaires. Be randomly assigned to either the VIS-assisted DBE group or the usual care group.\n\nReceive 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.\n\nComplete follow-up assessments after the 4-week intervention, including symptom and quality-of-life questionnaires",[28,29],"Functional Heartburn (FH)","Reflux Hypersensitivity",[31,29,32,33,34,35,36],"Functional Heartburn","Volume-Oriented Incentive Spirometry","Diaphragmatic Breathing Exercise","Disorders of Gut-Brain Interaction","Autonomic Nervous System","Quality of Life","NOT_YET_RECRUITING","2026-07-10",{"date":40,"type":41},"2026-07-15","ACTUAL",{"date":43,"type":22},"2026-08-20",{"date":45,"type":22},"2028-07-30",{"name":47,"class":48},"Changhua Christian Hospital","OTHER"]