Respiratory PhysiologyNCT06435793
Expiratory Pressure in Healthy Individuals
A study testing MEP measurement - Surface EMG in people with Respiratory Physiology, run by Laboratory of Movement, Condorcet, Tournai, Belgium at 1 site in Belgium.
Trial summary
The present study aims at enhancing our understanding of the influence of the mouthpiece configuration on the amplitude of oral pressures generated during a maximum expiratory pressure maneuver and on the neuromuscular recruitment of expiratory muscles (more specifically of the internal oblique and the transverse… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Physiology
- What is being tested?
- MEP measurement - Surface EMG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Sep 2024to 31 Oct 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18
Who cannot join
- Any neuromuscular disease or condition susceptible to interfere with the results
- Pregnant women
- Any contraindications to the realization of maximal expiratory maneuvers, as defined in the ATS Pulmonary Function Laboratory Management And Procedure Manual (3rd Edition)
- Excessive abdominal gird, compromising ultrasonographic positioning of electrodes or altering signal quality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining Factors of the Maximal Expiratory Pressure in Healthy Individuals: Influence of the Mouthpiece Configuration
The present study aims at enhancing our understanding of the influence of the mouthpiece configuration on the amplitude of oral pressures generated during a maximum expiratory pressure maneuver and on the neuromuscular recruitment of expiratory muscles (more specifically of the internal oblique and the transverse abdominal muscles).
Read the detailed description
Enhancing our understanding of the influence of the mouthpiece configuration on oral pressures and on the neuromuscular recruitment of the internal oblique and the transverse abdominal muscles during a maximum expiratory pressure (MEP) maneuver is the primary goal of this study
Maximal Respiratory Mouth Pressures (MIP and MEP):
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) are commonly used indices to assess respiratory muscle strength at the mouth.
MIP measures the strength of inspiratory muscles, while MEP assesses expiratory muscle strength.
These measurements are simple, convenient, and noninvasive. However, clear standards for these measurements are not well-established.
Choice of Mouthpiece:
We propose exploring different mouthpiece designs to know their impact on pressure measurements.
Influence of Mouthpiece Design:
The type of mouthpiece used can affect pressure measurements. Some investigators recommend including a small leak in the measuring circuit to dissipate pressure generated in the mouth and minimize measurement errors.
However, specific studies focusing on the influence of mouthpiece design on MEP and neuromuscular recruitment of expiratory muscles (such as the internal oblique and transverse muscles) during MEP maneuvers would be valuable.
Additional Considerations:
Factors like body position (sitting vs. half-lying) may also impact pressure measurements, although no significant differences were found in one study.
Among the objectives of our study, we aim at exploring ways to improve the accuracy and reliability of respiratory pressure measurements.
In summary, understanding the impact of mouthpiece design on oral pressures during MEP maneuvers is essential for accurate assessment of respiratory muscle function. Further research in this area could provide valuable insights for clinical practice and pulmonary function laboratories.
- Conditions
- Respiratory Physiology
- Being tested
- MEP measurement - Surface EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEP measurement - Surface EMGOther
Participants will undergo serial expiratory maneuvers using different mouthpieces.
At each maneuver, the maximal expiratory mouth pressure at total lung capacity will be measured, alongside with the degree of neuromuscular activation of the internal oblique and transverse abdominal muscles using surface electromyography.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Not described Receives: Other: MEP measurement - Surface EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal expiratory pressure
Measured: 120 minutes
Root mean square of the EMG signal
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start18 Sep 2024
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory PhysiologyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratory of Movement, Condorcet, Tournai, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mons
- Responsible party
- Principal investigator, Dr F Duprez, University of Mons
- Investigators
- Alexandre Legrand (MD, PhD), Physician, PhD, Principal investigator, University of MonsFrederic Duprez (PhD), Principal investigator, Provincial High School of Hainaut, CondorcetEliot Rudy Mbolo Ebubu (MD, PhD candidate), Principal investigator, University of MonsAlexandra Tassin, Biomedical scientist, Principal investigator, University of Mons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435793
- Sponsor's protocol ID
- P2024/081
- Status last verified
- Feb 2026
- First submitted
- 26 May 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Factors of the Maximal Expiratory Pressure in Healthy Individuals: Influence of the Mouthpiece Configuration
- ClinicalTrials.gov ID
- NCT06435793
- Acronym / sponsor ID
- P2024/081
- Conditions
- Respiratory Physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Laboratory of Movement, Condorcet, Tournai, BelgiumUniversity, hospital or other
- Collaborators
- University of Mons
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 30 May 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.
The present study aims at enhancing our understanding of the influence of the mouthpiece configuration on the amplitude of oral pressures generated during a maximum expiratory pressure maneuver and on the neuromuscular recruitment of expiratory muscles (more specifically of the internal oblique and the transverse abdominal muscles).
Detailed description
Enhancing our understanding of the influence of the mouthpiece configuration on oral pressures and on the neuromuscular recruitment of the internal oblique and the transverse abdominal muscles during a maximum expiratory pressure (MEP) maneuver is the primary goal of this study
Maximal Respiratory Mouth Pressures (MIP and MEP):
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) are commonly used indices to assess respiratory muscle strength at the mouth.
MIP measures the strength of inspiratory muscles, while MEP assesses expiratory muscle strength.
These measurements are simple, convenient, and noninvasive. However, clear standards for these measurements are not well-established.
Choice of Mouthpiece:
We propose exploring different mouthpiece designs to know their impact on pressure measurements.
Influence of Mouthpiece Design:
The type of mouthpiece used can affect pressure measurements. Some investigators recommend including a small leak in the measuring circuit to dissipate pressure generated in the mouth and minimize measurement errors.
However, specific studies focusing on the influence of mouthpiece design on MEP and neuromuscular recruitment of expiratory muscles (such as the internal oblique and transverse muscles) during MEP maneuvers would be valuable.
Additional Considerations:
Factors like body position (sitting vs. half-lying) may also impact pressure measurements, although no significant differences were found in one study.
Among the objectives of our study, we aim at exploring ways to improve the accuracy and reliability of respiratory pressure measurements.
In summary, understanding the impact of mouthpiece design on oral pressures during MEP maneuvers is essential for accurate assessment of respiratory muscle function. Further research in this area could provide valuable insights for clinical practice and pulmonary function laboratories.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Other: MEP measurement - Surface EMG |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age over 18
Key exclusion criteria (4 listed)
- Any neuromuscular disease or condition susceptible to interfere with the results
- Pregnant women
- Any contraindications to the realization of maximal expiratory maneuvers, as defined in the ATS Pulmonary Function Laboratory Management And Procedure Manual (3rd Edition)
- Excessive abdominal gird, compromising ultrasonographic positioning of electrodes or altering signal quality
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 |
|---|---|---|
| MEP measurement - Surface EMGParticipants will undergo serial expiratory maneuvers using different mouthpieces. At each maneuver, the maximal expiratory mouth pressure at total lung capacity will be measured, alongside with the degree of neuromuscular activation of the internal oblique and transverse abdominal muscles using surface electromyography. | Other | Healthy subjects |
Primary outcome
Maximal expiratory pressure
Time frame: 120 minutes
Root mean square of the EMG signal
Time frame: 120 minutes
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 25 Feb 2026.
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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. This study is not recruiting at the moment.
Alexandre Legrand (MD, PhD), Physician, PhD principal investigator
University of Mons
Frederic Duprez (PhD) principal investigator
Provincial High School of Hainaut, Condorcet
Eliot Rudy Mbolo Ebubu (MD, PhD candidate) principal investigator
University of Mons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEP measurement - Surface EMG in people with Respiratory Physiology, run by Laboratory of Movement, Condorcet, Tournai, Belgium at 1 site in Belgium.
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 4 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 25 Feb 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 Belgium. 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?
Maximal expiratory pressure (time frame: 120 minutes). The study lists 2 primary outcomes in all. 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 25 Feb 2026.