Healthy Adult ParticipantsTMS-RMTNCT07737015
Effects of Respiratory Muscle Training on Tongue Corticomotor Excitability
A study testing IMT and EMT in people with Healthy Adult Participants, run by Université Catholique de Louvain at 1 site in Denmark.
Trial summary
The tongue plays a central role in essential oral functions, including swallowing, speech, and upper airway control. Its coordinated interaction with the respiratory system is particularly relevant in clinical conditions such as obstructive sleep apnea and dysphagia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- IMT and EMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2024to 6 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- good general health
- ability to read and understand the project information
Who cannot join
- medical, physical or psychological disorder
- metal implants in the head
- medications affecting the nervous system
- craniofacial abnormalities
- neuromuscular or inflammatory diseases
- history of epilepsy
- presence of pacemaker or implanted medical devices
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Short Bout of Respiratory Muscle Training on Tongue Corticomotor Excitability in Healthy Adults: A Pilot Study
The tongue plays a central role in essential oral functions, including swallowing, speech, and upper airway control. Its coordinated interaction with the respiratory system is particularly relevant in clinical conditions such as obstructive sleep apnea and dysphagia. While respiratory muscle training is increasingly used in these contexts, its effects on the neural control of tongue function remain poorly understood.
This randomized cross-over pilot study aimed to investigate the acute effects of inspiratory (IMT) and expiratory (EMT) muscle training on tongue corticomotor excitability using transcranial magnetic stimulation. These results will provide novel insight into the neurophysiological mechanisms linking respiratory interventions and oral motor control.
- Conditions
- Healthy Adult Participants
- Being tested
- IMT, EMT
- Keywords
- Transcranial magnetic stimulation, tongue, motor-evoked potentials, respiratory muscle training, corticomotor excitability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMTDevice
An inspiratory threshold loading device set at 50% of the baseline maximal inspiratory pressure (PImax) was used. The training session consisted of five cycles of 20 breaths performed against the device, with a 2-minute rest period between cycles. Each breath consisted of quiet exhalation through the device, followed by a deep and forceful inspiration against the prescribed load.
EMTDevice
An expiratory threshold loading device set at 50% of the baseline maximal expiratory pressure (PEmax) was used. The training session consisted of five cycles of 20 breaths performed against the device, with a 2-minute rest period between cycles. Each breath consisted of quiet inhalation through the device, followed by a deep and forceful expiration against the set load.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Participants will perform a short term session of inspiratory muscle training, using an adjustable external load. Receives: Device: IMT |
| Expiratory muscle training | Experimental | Participants will perform a short term session of expiratory muscle training, using an adjustable external load Receives: Device: EMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor-evoked potentials
The amplitude of tongue-related motor-evoked potentials are assessed using transcranial magnetic stimulation over the tongue motor cortex.
Measured: Measured two times: immediately before the training session (baseline) and immediately after completion of the training session (approximately 45 minutes after baseline)
Secondary outcomes (2)
Maximum Inspiratory and Expiratory Pressure
Maximum Inspiratory and Expiratory pressure will be measured via the POWERBreathe device
Measured: Measured two times: immediately before the training session (baseline) and immediately after completion of the training session (approximately 45 minutes after baseline)
Tongue elevation peak pressure
Tongue peak pressure during elevation movements will be measured via the IOPI device
Measured: Measured two times: immediately before the training session (baseline) and immediately after completion of the training session (approximately 45 minutes after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Oct 2024
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
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
- NCT07737015
- Sponsor's protocol ID
- TMS-RMT
- Acronym
- TMS-RMT
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Short Bout of Respiratory Muscle Training on Tongue Corticomotor Excitability in Healthy Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT07737015
- Acronym / sponsor ID
- TMS-RMT / TMS-RMT
- Conditions
- Healthy Adult Participants
- Keywords
- Transcranial magnetic stimulation, tongue, motor-evoked potentials, respiratory muscle training, corticomotor excitability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 30 Jul 2026 (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.
The tongue plays a central role in essential oral functions, including swallowing, speech, and upper airway control. Its coordinated interaction with the respiratory system is particularly relevant in clinical conditions such as obstructive sleep apnea and dysphagia. While respiratory muscle training is increasingly used in these contexts, its effects on the neural control of tongue function remain poorly understood.
This randomized cross-over pilot study aimed to investigate the acute effects of inspiratory (IMT) and expiratory (EMT) muscle training on tongue corticomotor excitability using transcranial magnetic stimulation. These results will provide novel insight into the neurophysiological mechanisms linking respiratory interventions and oral motor control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Device: IMTParticipants will perform a short term session of inspiratory muscle training, using an adjustable external load. |
| Expiratory muscle training | Experimental | Device: EMTParticipants will perform a short term session of expiratory muscle training, using an adjustable external load |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- good general health
- ability to read and understand the project information
Key exclusion criteria (8 listed)
- medical, physical or psychological disorder
- metal implants in the head
- medications affecting the nervous system
- craniofacial abnormalities
- neuromuscular or inflammatory diseases
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 |
|---|---|---|
| IMTAn inspiratory threshold loading device set at 50% of the baseline maximal inspiratory pressure (PImax) was used. The training session consisted of five cycles of 20 breaths performed against the device, with a 2-minute rest period between cycles. Each breath consisted of quiet exhalation through the device, followed by a deep and forceful inspiration against the prescribed load. | Device | Inspiratory Muscle Training |
| EMTAn expiratory threshold loading device set at 50% of the baseline maximal expiratory pressure (PEmax) was used. The training session consisted of five cycles of 20 breaths performed against the device, with a 2-minute rest period between cycles. Each breath consisted of quiet inhalation through the device, followed by a deep and forceful expiration against the set load. | Device | Expiratory muscle training |
Primary outcome
Motor-evoked potentials
Time frame: Measured two times: immediately before the training session (baseline) and immediately after completion of the training session (approximately 45 minutes after baseline)
The amplitude of tongue-related motor-evoked potentials are assessed using transcranial magnetic stimulation over the tongue motor cortex.
2 secondary outcomes
Maximum Inspiratory and Expiratory Pressure
Time frame: Measured two times: immediately before the training session (baseline) and immediately after completion of the training session (approximately 45 minutes after baseline)
Tongue elevation peak pressure
Time frame: Measured two times: immediately before the training session (baseline) and immediately after completion of the training session (approximately 45 minutes after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Adult Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
RecruitingObservational study
Magnetic Field Maps With NV Application Kit MCG
Technical Feasibility and Performance of the Sensor System, Healthy Adult
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: 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 Adult Participants, run by Université Catholique de Louvain at 1 site in Denmark.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor-evoked potentials (time frame: Measured two times: immediately before the training session (baseline) and immediately after completion of the training session (approximately 45 minutes after baseline)). 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 30 Jul 2026.