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Effect of Inspiratory Muscle Training on Symptom Severity and Quality of Life in Non-Erosive Reflux Disease

StatusNot Yet Recruiting
PhaseNot applicable
Started2026-07-22
View on ClinicalTrials.gov ↗

Amendment history

2026-06-23
minor
Study Status, Eligibility v1
Start date2026-06-15→2026-07-22
Eligibility criteria+83 characters
[...] reflux symptoms for at least 3 months. Exclusion Criteria: UsingCurrent use of proton pump inhibitors (PPIs) or failure to complete a minimum 2-week washout period before enrollment. With known gastroduodenal ulcers Diagnosed with erosive eso [...]
2026-05-06
minor
Original filing
The goal of this clinical trial is to learn if inspiratory muscle training (IMT) works to treat on clinical symptom severity and quality of life in patients with Non-erosive reflux disease (NERD). The main questions it aims to answer are: Does drug IMT lower the clinical symptom severity ? Does drug IMT improve quality of life? Researchers will compare high intensity IMT to a sham-IMT (a IMT device with no resistance) to see if IMT lower the clinical symptom severity and improve improve quality of life. Participants will perform the following protocol: The IMT protocol will consist of home-based high-intensity training using a Threshold IMT device: two sets of 30 breaths with a 1-minute rest, twice daily for 4 weeks. The study group will train at 60% of baseline maximum inspiratory pressure (MIP), with weekly adjustments based on modified Borg scores (4-6), while the control group will perform sham IMT without resistance.
Trial Details
NCT Number NCT07584096
Lead Sponsor Izmir University of Economics
Conditions Non-erosive Reflux Disease (NERD)
Enrollment 60 participants
Start Date 2026-07-22
Primary Completion 2026-12-15 (estimated)
Study Completion 2027-05-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-24