Clinical trial NCT06627283: Effects of Respiratory Muscle Training on Tongue Muscle Function
Official title: Effects of Respiratory Muscle Training on Tongue Muscle Function in Healthy Subjects, a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: In patient with obstructive sleep apnea, studies have shown that respiratory muscle training improved sleep-related outcomes in patients with obstructive sleep apnea (OSA). On the other hand, a recent study showed that expiratory muscle training improved tongue motor strength in patients with OSA. We hypothesize that respiratory muscle training (either Inspiratory Muscle Training (IMT) or Expiratory Muscle Training (EMT)) may elicit sleep-related improvement in patient with OSA through enhancement on tongue muscle function.

To investigate our hypothesis, we will first address this question in a population of healthy subjects. This study will therefore investigate the effects of respiratory muscle training on tongue muscle function in healthy subjects. The primary hypothesis is that the IMT program with lead to an increase in tongue strength compared to the control group. Other hypothesizes are that EMT, but not sham, will also lead to an increase in tongue strength, compared to the control group.

Eligibility 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) \&gt; 100 beats per minute (bpm) or \&lt; 50 bpm; resting systolic blood pressure (SBP) \&gt; 140 or \&lt; 90 mmHg, diastolic blood pressure (DBP) \&gt; 90 or \&lt; 50 mmHg; oxygen saturation (SpO2) \&lt; 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 outcomes:
measure: Tongue elevation strength
timeFrame: Measured two times: at baseline and after 8 weeks
Secondary outcomes:
measure: Tongue protrustion strength
timeFrame: Measured two times: at baseline and after 8 weeks
measure: Tongue elevation endurance
timeFrame: Measured two times: at baseline and after 8 weeks
measure: Tongue protrusion endurance
timeFrame: Measured two times: at baseline and after 8 weeks
measure: Maximal inspiratory pressure
timeFrame: Measured two times: at baseline and after 8 weeks
measure: Maximal expiratory pressure
timeFrame: Measured two times: at baseline and after 8 weeks
measure: Snoring intensity
timeFrame: Measured two times: at baseline and after 8 weeks
measure: Tongue base thickness
timeFrame: Measured two times: at baseline and after 8 weeks
measure: Total sagittal thickness
timeFrame: Measured two times: at baseline and after 8 weeks
measure: Lateral pharyngeal wall thickness
timeFrame: Measured two times: at baseline and after 8 weeks
measure: Snoring duration
timeFrame: Measured two times: at baseline and after 8 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KULeuven
city: Louvain-La-Neuve
country: Belgium
facility: UCLouvain
city: Lausanne
country: Switzerland
facility: HESAV
Study officials:
References: