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.

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: IMT; Device: EMT; Device: Sham

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William Poncin; Phone Number: +3227642316; Email: william.poncin@uclouvain.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • KULeuven
    • Contact: Daniel Langer; Phone Number: +3216330192; Email: daniel.langer@kuleuven.be
  • Louvain-la-Neuve, Belgium, 1348
    • Recruiting
    • UCLouvain
    • Contact: William Poncin; Email: william.poncin@uclouvain.be
    • Sub-Investigator: Julien Da Purificaçao
• Switzerland
  • Lausanne, Switzerland, 1011
    • Recruiting
    • HESAV
    • Contact: Olivier Contal, PhD; Phone Number: +41213168122; Email: olivier.contal@hesav.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Sham Comparator: Sham	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.
Active Comparator: IMT	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.
Active Comparator: EMT	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue protrustion strength	Tongue protrusion strength (peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI).	Measured two times: at baseline and after 8 weeks
Tongue elevation endurance	Tongue elevation endurance (50% of peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI).	Measured two times: at baseline and after 8 weeks
Tongue protrusion endurance	Tongue protrusion endurance (50% of peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI).	Measured two times: at baseline and after 8 weeks
Maximal inspiratory pressure	Maximal inspiratory pressure will be measured at functional residual capacity (FRC)	Measured two times: at baseline and after 8 weeks
Maximal expiratory pressure	Maximal expiratory pressure will be measured at total lung capacity (TLC)	Measured two times: at baseline and after 8 weeks
Snoring intensity	The participants' bed partners (if applicable) will be asked to rate their partner´s snoring using a Visual Analog Scale (VAS), which ranked the impact of snoring from 0 (no snoring) to 10 (intolerable).	Measured two times: at baseline and after 8 weeks
Tongue base thickness	This measurement will be performed with a portable ultrasound machine	Measured two times: at baseline and after 8 weeks
Total sagittal thickness	This measurement will be performed with a portable ultrasound machine	Measured two times: at baseline and after 8 weeks
Lateral pharyngeal wall thickness	This measurement will be performed with a portable ultrasound machine	Measured two times: at baseline and after 8 weeks
Snoring duration	This recording will be conducted using the standard microphone application installed on the participant's personal phone and through the use of the free, already validated in studies, SnoreLab application.	Measured two times: at baseline and after 8 weeks

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RMT-TONGUE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No