HealthyNCT06627283
Effects of Respiratory Muscle Training on Tongue Muscle Function
A study testing IMT and EMT in people with Healthy, run by Université Catholique de Louvain at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IMT and EMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 4 Nov 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Belgium2 sites, 2 recruiting
- Recruiting
KULeuven
Leuven, 3000
Daniel Langer, +3216330192, daniel.langer@kuleuven.be
- Recruiting
UCLouvain
Louvain-la-Neuve, 1348
William Poncin, william.poncin@uclouvain.be
Julien Da Purificaçao
Switzerland1 site, 1 recruiting
- Recruiting
HESAV
Lausanne, 1011
Olivier Contal, PhD, +41213168122, olivier.contal@hesav.ch
About this study
Official title: 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.
Read the 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
- Being tested
- IMT, EMT, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMTDevice
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.
EMTDevice
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.
ShamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| IMT | Active comparator | Not described Receives: Device: IMT |
| EMT | Active comparator | Not described Receives: Device: EMT |
| Sham | Sham comparator | Not described Receives: Device: Sham |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue elevation strength
Tongue elevation strength (peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI).
Measured: Measured two times: at baseline and after 8 weeks
Secondary outcomes (10)
Tongue protrustion strength
Tongue protrusion strength (peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI).
Measured: 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: 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: Measured two times: at baseline and after 8 weeks
Maximal inspiratory pressure
Maximal inspiratory pressure will be measured at functional residual capacity (FRC)
Measured: Measured two times: at baseline and after 8 weeks
Maximal expiratory pressure
Maximal expiratory pressure will be measured at total lung capacity (TLC)
Measured: 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: Measured two times: at baseline and after 8 weeks
Tongue base thickness
This measurement will be performed with a portable ultrasound machine
Measured: Measured two times: at baseline and after 8 weeks
Total sagittal thickness
This measurement will be performed with a portable ultrasound machine
Measured: Measured two times: at baseline and after 8 weeks
Lateral pharyngeal wall thickness
This measurement will be performed with a portable ultrasound machine
Measured: 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: Measured two times: at baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start4 Nov 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Poncin, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627283
- Sponsor's protocol ID
- RMT-TONGUE
- Status last verified
- Apr 2026
- First submitted
- 2 Oct 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Muscle Training on Tongue Muscle Function in Healthy Subjects, a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06627283
- Acronym / sponsor ID
- RMT-TONGUE
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IMT | Active comparator | Device: IMT |
| EMT | Active comparator | Device: EMT |
| Sham | Sham comparator | Device: Sham |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMTDescription: 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 | IMT |
| EMTA 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 | EMT |
| ShamA 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. | Device | Sham |
Primary outcome
Tongue elevation strength
Time frame: Measured two times: at baseline and after 8 weeks
Tongue elevation strength (peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI).
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMT and EMT in people with Healthy, run by Université Catholique de Louvain at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Poncin (+3227642316, william.poncin@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tongue elevation strength (time frame: Measured two times: at baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.