Effects of Respiratory Muscle Training on Tongue Muscle Function

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Device: EMT; Device: IMT; Device: Sham

• Registration Number: NCT06627283
• Lead Sponsor: Université Catholique de Louvain

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.

Study Timeline

• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-04
• Study Start: 2024-11-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-11-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMT	EMT	-
IMT	IMT	-
Sham	Sham	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Tongue protrustion strength	Measured two times: at baseline and after 8 weeks	Tongue protrusion strength (peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI).
Tongue elevation endurance	Measured two times: at baseline and after 8 weeks	Tongue elevation endurance (50% of peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI).
Tongue protrusion endurance	Measured two times: at baseline and after 8 weeks	Tongue protrusion endurance (50% of peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI).
Maximal inspiratory pressure	Measured two times: at baseline and after 8 weeks	Maximal inspiratory pressure will be measured at functional residual capacity (FRC)
Maximal expiratory pressure	Measured two times: at baseline and after 8 weeks	Maximal expiratory pressure will be measured at total lung capacity (TLC)
Snoring intensity	Measured two times: at baseline and after 8 weeks	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).
Tongue base thickness	Measured two times: at baseline and after 8 weeks	This measurement will be performed with a portable ultrasound machine
Total sagittal thickness	Measured two times: at baseline and after 8 weeks	This measurement will be performed with a portable ultrasound machine
Lateral pharyngeal wall thickness	Measured two times: at baseline and after 8 weeks	This measurement will be performed with a portable ultrasound machine
Snoring duration	Measured two times: at baseline and after 8 weeks	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.

Trial Locations

Locations (3)

KULeuven; 🇧🇪 Leuven, Belgium

UCLouvain; 🇧🇪 Louvain-La-Neuve, Belgium

HESAV; 🇨🇭 Lausanne, Switzerland