Investigating how respiratory muscle training affects tongue muscle function
Effects of Respiratory Muscle Training on Tongue Muscle Function in Healthy Subjects, a Randomized Controlled Trial.
NA · Université Catholique de Louvain · NCT06627283
This study is testing if breathing exercises can make tongue muscles stronger in healthy adults, which might help people with sleep apnea in the future.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Université Catholique de Louvain (other) |
| Locations | 3 sites (Leuven and 2 other locations) |
| Trial ID | NCT06627283 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the impact of respiratory muscle training on tongue muscle function in healthy individuals. The researchers hypothesize that both Inspiratory Muscle Training (IMT) and Expiratory Muscle Training (EMT) will enhance tongue strength compared to a control group. The study will involve community ambulant adults aged 18 to 65, who will undergo different training interventions to assess improvements in tongue muscle function. The findings may provide insights into potential benefits for patients with obstructive sleep apnea based on previous studies.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 with a BMI between 18 and 30.
Not a fit: Patients with neuromuscular or cardiorespiratory diseases, psychiatric disorders, or diagnosed obstructive sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for conditions like obstructive sleep apnea by enhancing tongue muscle function.
How similar studies have performed: Previous studies have shown positive outcomes with respiratory muscle training in patients with obstructive sleep apnea, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Leuven and 2 other locations
- KULeuven — Leuven, Belgium (RECRUITING)
- UCLouvain — Louvain-la-Neuve, Belgium (RECRUITING)
- HESAV — Lausanne, Switzerland (RECRUITING)
Study contacts
- Study coordinator: William Poncin
- Email: william.poncin@uclouvain.be
- Phone: +3227642316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy