Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Belgium / NCT06627283
Recruiting Not applicable

Effects of Respiratory Muscle Training on Tongue Muscle Function

NCT06627283 · tracked via the Priya Life Science Belgium tracker
Sponsor
Université Catholique de Louvain
Phase
Not applicable
Started
2024-11-04
Last updated
2026-04-29

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

IMTEMTSham

IMT: Description: A pressure threshold loading device will be used: the POWERbreathe Medic (load range 10-90 cmH2O). Participants will be instructed to exhale passively during normal tidal breathing through the training device (until functional residual capacity) and to perform deep inspirations against the external load. The first week, the resistance will be fixed at 30% of the baseline measured maximal inspiratory pressure (MIP). Participants will be instructed to increase the resistance by 10% of the baseline set resistance each week.

EMT: A pressure threshold loading device will be used: the POWERbreathe Ex1 EMT Medic (load range 10-90 cmH2O) or POWERbreathe Ex1 EMT MR (load range 35-175 cmH2O) depending on their baseline MEP measurement. Participants will be instructed to inhale quietly during normal tidal breathing through the training device and to perform rapid and deep exhalation against the external load. The first week, the resistance will be fixed at 30% of the baseline measured MEP. Participants will be instructed to increase the resistance by 10% of the baseline set resistance each week.

Sham: A pressure threshold loading device will be used: the POWERbreathe Ex1 EMT Medic or MR, but with the resistance mechanism inside removed and replaced by a plastic ball. The same instructions will be given as for the EMT group, except that there will be no or minimal resistance (less than 6 cmH2O). There will be no change in resistance over the weeks.

Study summary

This study aims to investigate the effects of respiratory muscle training on tongue muscle function in healthy subjects. We hypothesize that respiratory muscle training can improve strength and endurance of the tongue muscles.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: Community ambulant adults between 18 to 65 years old as of testing day; able to understand French or Dutch (depending on the study's site of inclusion); BMI ≥ 18 and ≤ 30 kg/m². Exclusion Criteria: Any diagnosed neuromuscular or cardiorespiratory disease; diagnosed psychiatric or psychological disorders which could affect adherence to or comprehension of instructions; diagnosed eating disorders; previous or ongoing head and neck cancer; diagnosed OSA; presenting a high-risk of sleep-disordered breathing indicated by a NoSAS score of 8 or higher 32 or a STOP-Bang score of 3 or higher 33,34; resting heart rate (HR) \> 100 beats per minute (bpm) or \< 50 bpm; resting systolic blood pressure (SBP) \> 140 or \< 90 mmHg, diastolic blood pressure (DBP) \> 90 or \< 50 mmHg; oxygen saturation (SpO2) \< 94% at rest on room air. Individuals with abnormal lung function, i.e., forced expiratory volume in 1 second (FEV1) ≤ 80%, forced vital capacity (FVC) ≤ 80%, and FEV1/FVC ≤ 70%, will also be excluded.

Primary outcome measure(s)

  • Tongue elevation strength — Measured two times: at baseline and after 8 weeks
    Tongue elevation strength (peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI).

Trial sites (3)

FacilityCityRegionStatus
KULeuven Leuven Belgium Recruiting
UCLouvain Louvain-la-Neuve Belgium Recruiting
HESAV Lausanne Switzerland Recruiting

More Université Catholique de Louvain trials in Belgium

Assessment of a New Tool to Measure Tongue Muscle Function Recruiting
Study of Lipid Mediators in Chronic Postoperative Pain - LICP Recruiting
Tongue Muscular Assessment in Healthy Children Recruiting
Immune Cells Role in Lung Cancer and Their Use in Anticancer Immunotherapies and Inflammatory Lung Disease Recruiting
Sex-difference in Response to Resistance Exercise and Training Enrolling by invitation

Other trials for the same condition

Assessment of a New Tool to Measure Tongue Muscle Function Recruiting
Tongue Muscular Assessment in Healthy Children Recruiting
International (Pediatric) Peritoneal Biobank Recruiting
The Influence of Cortical Lateralization on Selective Motor Control of the Arm Swing During Independent Walking After Stroke. Recruiting
Reject Analysis of Periapical Radiographs of Dental Implants. Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06627283 on ClinicalTrials.gov ↗ ← All trials in Belgium