NCT07584096

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026May 2027

First Submitted

Initial submission to the registry

May 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 22, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

May 6, 2026

Last Update Submit

June 23, 2026

Conditions

Non-erosive Reflux Disease (NERD)

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (3)

  • Inspiratory Muscle Strength

    4 weeks

  • Gastroesophageal Reflux Disease-Related Quality of Life

    4 weeks

  • Change in Diagnostic Symptom Score

    4 weeks

Study Arms (2)

Study Group

EXPERIMENTAL

Patients who will perform inspiratory muscle training (IMT) with %60 loading

Device: Inspiratory Muscle Training (IMT)

Sham Group

SHAM COMPARATOR

Patients who will perform Sham IMT

Device: Sham IMT

Interventions

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.

Sham Group
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.

Study Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A clinical diagnosis of NERD,
  • No erosive lesions on endoscopy,
  • Presence of reflux symptoms for at least 3 months.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir University of Economics

Izmir, Balçova, 35330, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 34325496BACKGROUND

  • Aktan 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 Jan 24. doi: 10.1007/s00192-026-06517-7. Online ahead of print.

    PMID: 41579192BACKGROUND

  • Fass 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.

    PMID: 19262545BACKGROUND

  • Hershcovici 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.

    PMID: 20535321BACKGROUND

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

Gastroesophageal RefluxEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Rıdvan Aktan, Assoc Prof.

    İzmir University of Economics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rıdvan Aktan, Assoc Prof.

CONTACT

+905453318172ridvanaktan@gmail.com

Nilay Danış, Assoc Prof.

CONTACT

+90 2324123704nilaydanis17@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof., PhD

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 13, 2026

Study Start

July 22, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

May 15, 2027

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)