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.

Overview

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.

Interventions

• Device 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
• Device 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 inc
• Device 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.

Primary outcome measures

• Tongue elevation strength [Time frame: Measured two times: at baseline and after 8 weeks]

Secondary outcome measures (10)

• Tongue protrustion strength [Time frame: Measured two times: at baseline and after 8 weeks]
• Tongue elevation endurance [Time frame: Measured two times: at baseline and after 8 weeks]
• Tongue protrusion endurance [Time frame: Measured two times: at baseline and after 8 weeks]
• Maximal inspiratory pressure [Time frame: Measured two times: at baseline and after 8 weeks]
• Maximal expiratory pressure [Time frame: Measured two times: at baseline and after 8 weeks]
• Snoring intensity [Time frame: Measured two times: at baseline and after 8 weeks]
• Tongue base thickness [Time frame: Measured two times: at baseline and after 8 weeks]
• Total sagittal thickness [Time frame: Measured two times: at baseline and after 8 weeks]
• Lateral pharyngeal wall thickness [Time frame: Measured two times: at baseline and after 8 weeks]
• Snoring duration [Time frame: Measured two times: at baseline and after 8 weeks]

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) \> 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Belgium · 2 centers

• KULeuven — Leuven
• UCLouvain — Louvain-la-Neuve

Switzerland · 1 center

• HESAV — Lausanne

Identifiers

NCT: NCT06627283 · RMT-TONGUE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗