NCT06627283

Effects of Respiratory Muscle Training on Tongue Muscle Function

Effects of Respiratory Muscle Training on Tongue Muscle Function in Healthy Subjects, a Randomized Controlled Trial.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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 the baseline set resistance each week.
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 increase the resistance by 10% of the baseline set resistance each week.
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.

Timeline

• Start date: 2024-11-04
• Primary completion: 2025-11-01
• Completion: 2026-03-01
• First posted: 2024-10-04
• Last updated: 2024-12-10

Locations

3 sites across 2 countries: Belgium, Switzerland