MedDataX Logo

Effects of Respiratory Muscle Training on Tongue Muscle Function

NCT ID: NCT06627283

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2026-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IMT

Group Type ACTIVE_COMPARATOR

IMT

Intervention Type DEVICE

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.

EMT

Group Type ACTIVE_COMPARATOR

EMT

Intervention Type DEVICE

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.

Sham

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

William Poncin

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

KULeuven

Leuven, , Belgium

Site Status RECRUITING

UCLouvain

Louvain-la-Neuve, , Belgium

Site Status RECRUITING

HESAV

Lausanne, , Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

William Poncin

Role: CONTACT

Phone: +3227642316

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Daniel Langer

Role: primary

William Poncin

Role: primary

Olivier Contal, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RMT-TONGUE

Identifier Type: -

Identifier Source: org_study_id