Effect of Inspiratory Muscle Training on Symptom Severity and Quality of Life in Non-Erosive Refl… (NCT07584096) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Inspiratory Muscle Training on Symptom Severity and Quality of Life in Non-Erosive Reflux Disease
Turkey (Türkiye)60 participantsStarted 2026-07-22
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A clinical diagnosis of NERD,
* No erosive lesions on endoscopy,
* Presence of reflux symptoms for at least 3 months.
Exclusion Criteria:
* Current 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 esophagitis
* With hiatal hernia
* With a history of gastrointestinal malignancy
* With infectious or inflammatory gastrointestinal diseases
* With malabsorption syndrome or gastrointestinal obstruction
* With a history of major gastrointestinal surgery (including anti-reflux, gastric, or duodenal surgery)
* With systemic sclerosis or other systemic connective tissue diseases
* With severe cardiovascular, pulmonary, renal, or hepatic disease
* With chronic respiratory diseases such as asthma or COPD
* Having had an acute respiratory tract infection within the past 4 weeks
* With neuromuscular diseases
* With active tuberculosis
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.