- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06435793
Expiratory Pressure in Healthy Individuals
Determining Factors of the Maximal Expiratory Pressure in Healthy Individuals: Influence of the Mouthpiece Configuration
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tournai, Belgium
- Haute Ecole Provinciale du Hainaut Condorcet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age over 18
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy subjects
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maximal expiratory pressure
Time Frame: 120 minutes
|
120 minutes
|
|
Root mean square of the EMG signal
Time Frame: 120 minutes
|
120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Orbicularis Oris Performance Index
Time Frame: 5 minutes
|
Obtained after computational processing of participant photographs using a MatLab based software.
This index is a newly developed marker of the Orbicularis Oris function based on different anthropometric variables
|
5 minutes
|
|
Orbicularis Oris strength
Time Frame: 10 minutes
|
Obtained through the Iowa Oral Performance Instrument
|
10 minutes
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Frederic Duprez (PhD), Provincial High School of Hainaut, Condorcet
- Principal Investigator: Eliot Rudy Mbolo Ebubu (MD, PhD candidate), University of Mons
- Principal Investigator: Alexandre Legrand (MD, PhD), Physician, PhD, University of Mons
- Principal Investigator: Alexandra Tassin, Biomedical scientist, University of Mons
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P2024/081
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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