Non-erosive Reflux Disease (NERD)NCT07584096
Effect of Inspiratory Muscle Training on Symptom Severity and Quality of Life in Non-Erosive Reflux Disease
A study testing Inspiratory Muscle Training (IMT) in people with Non-erosive Reflux Disease (NERD), run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-erosive Reflux Disease (NERD)
- What is being tested?
- Inspiratory Muscle Training (IMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jul 2026to 15 May 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of NERD,
- No erosive lesions on endoscopy,
- Presence of reflux symptoms for at least 3 months.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Izmir University of Economics
Izmir, Balçova, 35330
Rıdvan Aktan, Assoc Prof., +902324888579, ridvanaktan@gmail.com
Nilay Danış, Assoc Prof.
About this study
Official title: Effect of Inspiratory Muscle Training on Clinical Symptom Severity and Quality of Life in Patients With Non-erosive Reflux Disease: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-minute rest between sets, twice a day for 4 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The IMT was performed twice a day, 7 days/week, for 4 weeks. The study group performed IMT at 60% of their baseline MIP and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session, while the control group performed a sham-IMT without applied resistance. Patients are evaluated before the inspiratory muscle training and after 4 weeks of training.
- Conditions
- Non-erosive Reflux Disease (NERD)
- Being tested
- Inspiratory Muscle Training (IMT), Sham IMT
- Medical subject headings
- Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training (IMT)Device
The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 60% of each patient's maximal inspiratory pressure, measured and adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session.
Sham IMTDevice
The IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Patients who will perform inspiratory muscle training (IMT) with %60 loading Receives: Device: Inspiratory Muscle Training (IMT) |
| Sham Group | Sham comparator | Patients who will perform Sham IMT Receives: Device: Sham IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Severity
The Reflux Disease Questionnaire (RDQ) will be used to measure the severity of clinical symptoms. The RDQ is a 12-item self-report scale that assesses the frequency and severity of upper gastrointestinal symptoms over the past week. Each item is rated on a Likert scale from 0 to 5, and the total score is calculated as the average of the relevant items. A higher score indicates more severe symptoms.
Measured: 4 weeks
Secondary outcomes (3)
Inspiratory Muscle Strength
The Inspiratory muscle strength was evaluated by maximum inspiratory pressure which was assessed with a digital mouth pressure meter device (MicroRPM, Micro Medical Ltd., Rochester, Kent, United Kingdom), and recorded in cmH2O (centimeter-water).
Measured: 4 weeks
Gastroesophageal Reflux Disease-Related Quality of Life
The Gastroesophageal Reflux Disease Quality of Life Questionnaire (GERD-QOL) will be used. The questionnaire will be evaluated based on the total score, with a higher score indicating poorer quality of life.
Measured: 4 weeks
Change in Diagnostic Symptom Score
The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) will be used to assess changes in diagnostic symptom scores. A high score indicates severe symptoms.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start22 Jul 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-erosive Reflux Disease (NERD)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a prospective and Randomized Controlled experimental study. Participants were randomly divided into two groups in a 1:1 ratio; the study group and the control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ridvan Aktan, Izmir University of Economics
- Investigators
- Rıdvan Aktan, Assoc Prof., Principal investigator, İzmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584096
- Sponsor's protocol ID
- E-97429853-050.04- 124388
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang H. Sample size determination and power analysis using the G*Power software. J Educ Eval Health Prof. 2021;18:17. doi: 10.3352/jeehp.2021.18.17. Epub 2021 Jul 30.
PubMed 34325496Aktan R, Yakit Yesilyurt S, Ozalevli S, Sonbahar AE. Effects of Home-Based, Telerehabilitation-Assisted High-Intensity Inspiratory Muscle Training on Pelvic Floor Muscle Function and Urinary Symptoms in Women with Stress Urinary Incontinence: A Pilot Randomized Controlled Trial. Int Urogynecol J. 2026 Jun;37(6):1679-1688. doi: 10.1007/s00192-026-06517-7. Epub 2026 Jan 24.
PubMed 41579192Fass R. Proton pump inhibitor failure--what are the therapeutic options? Am J Gastroenterol. 2009 Mar;104 Suppl 2:S33-8. doi: 10.1038/ajg.2009.50.
PubMed 19262545Hershcovici T, Fass R. Nonerosive Reflux Disease (NERD) - An Update. J Neurogastroenterol Motil. 2010 Jan;16(1):8-21. doi: 10.5056/jnm.2010.16.1.8. Epub 2010 Jan 31.
PubMed 20535321
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training on Clinical Symptom Severity and Quality of Life in Patients With Non-erosive Reflux Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07584096
- Acronym / sponsor ID
- E-97429853-050.04- 124388
- Conditions
- Non-erosive Reflux Disease (NERD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Study start
- 22 Jul 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 13 May 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 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.
Detailed description
The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-minute rest between sets, twice a day for 4 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The IMT was performed twice a day, 7 days/week, for 4 weeks. The study group performed IMT at 60% of their baseline MIP and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session, while the control group performed a sham-IMT without applied resistance. Patients are evaluated before the inspiratory muscle training and after 4 weeks of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was designed as a prospective and Randomized Controlled experimental study. Participants were randomly divided into two groups in a 1:1 ratio; the study group and the control group.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Inspiratory Muscle Training (IMT)Patients who will perform inspiratory muscle training (IMT) with %60 loading |
| Sham Group | Sham comparator | Device: Sham IMTPatients who will perform Sham IMT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A clinical diagnosis of NERD,
- No erosive lesions on endoscopy,
- Presence of reflux symptoms for at least 3 months.
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Inspiratory Muscle Training (IMT)The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 60% of each patient's maximal inspiratory pressure, measured and adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session. | Device | Study Group |
| Sham IMTThe IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device. | Device | Sham Group |
Primary outcome
Symptom Severity
Time frame: 4 weeks
The Reflux Disease Questionnaire (RDQ) will be used to measure the severity of clinical symptoms. The RDQ is a 12-item self-report scale that assesses the frequency and severity of upper gastrointestinal symptoms over the past week. Each item is rated on a Likert scale from 0 to 5, and the total score is calculated as the average of the relevant items. A higher score indicates more severe symptoms.
3 secondary outcomes
Inspiratory Muscle Strength
Time frame: 4 weeks
Gastroesophageal Reflux Disease-Related Quality of Life
Time frame: 4 weeks
Change in Diagnostic Symptom Score
Time frame: 4 weeks
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 24 Jun 2026.
- Background: PubMed 34325496Kang H. Sample size determination and power analysis using the G*Power software. J Educ Eval Health Prof. 2021;18:17. doi: 10.3352/jeehp.2021.18.17. Epub 2021 Jul 30.
- Background: PubMed 41579192Aktan R, Yakit Yesilyurt S, Ozalevli S, Sonbahar AE. Effects of Home-Based, Telerehabilitation-Assisted High-Intensity Inspiratory Muscle Training on Pelvic Floor Muscle Function and Urinary Symptoms in Women with Stress Urinary Incontinence: A Pilot Randomized Controlled Trial. Int Urogynecol J. 2026 Jun;37(6):1679-1688. doi: 10.1007/s00192-026-06517-7. Epub 2026 Jan 24.
- Background: PubMed 19262545Fass R. Proton pump inhibitor failure--what are the therapeutic options? Am J Gastroenterol. 2009 Mar;104 Suppl 2:S33-8. doi: 10.1038/ajg.2009.50.
- Background: PubMed 20535321Hershcovici T, Fass R. Nonerosive Reflux Disease (NERD) - An Update. J Neurogastroenterol Motil. 2010 Jan;16(1):8-21. doi: 10.5056/jnm.2010.16.1.8. Epub 2010 Jan 31.
- Individual participant dataSharing planned: No
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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.
Rıdvan Aktan, Assoc Prof. principal investigator
İzmir University of Economics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training (IMT) in people with Non-erosive Reflux Disease (NERD), run by Izmir University of Economics at 1 site in Turkey (Türkiye).
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 3 inclusion and 15 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Rıdvan Aktan, Assoc Prof. (+905453318172, ridvanaktan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Severity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07584096, which also lists 4 linked publications.
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 24 Jun 2026.