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Completed
NCT07744815
Mobile Application for Gastroesophageal Reflux Disease
Conditions: Gastroesophageal Reflux Esophagitis
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Fooyin University
Location: Yuan's General Hospital Kaohsiung City
Summary
Gastroesophageal reflux disease (GERD) is a chronic condition with frequent symptom recurrence that may negatively affect sleep quality and quality of life. This randomized controlled study aims to evaluate whether a mobile application developed as a mobile application, combined with standard education and diaphragmatic breathing training, can reduce symptom recurrence and improve sleep quality and quality of life in patients with GERD. Participants will be randomly assigned to either an intervention group receiving the mobile application or a control group receiving standard education. Outcomes will be assessed using the GerdQ, Reflux Symptom Index (RSI), GERD-HRQL, and Insomnia Severity Index (ISI) at baseline, 2 weeks, 4 weeks, and 8 weeks.
Eligibility Criteria
Inclusion Criteria:
* Age 18 to 60 years.
* Able to communicate in Mandarin Chinese or Taiwanese.
-.Owns and is able to use a smartphone.
* Endoscopically confirmed gastroesophageal reflux disease with Los Angeles (LA) Classification Grade B, C, or D erosive esophagitis, or Barrett's esophagus.
* Able and willing to provide written informed consent.
Exclusion Criteria:
* Previous esophageal or gastric surgery, including anti-reflux surgery.
* Regular use of proton pump inhibitors within the previous 8 weeks.
* Receiving antithrombotic therapy.
* Diabetes mellitus requiring treatment (HbA1c ≥ 6.5%).
* Liver cirrhosis (Child-Pugh class B or higher).
* Chronic kidney disease stage 3 or higher.
* Neurological disorders affecting participation.
* Malignancy other than early-stage cancer.
* Hiatal hernia larger than 2 cm.
Source: ClinicalTrials.gov (NCT07744815). StuddyBuddy aggregates publicly available trial information.