## Protocol Section
### Identification Module
**NCT ID:** NCT06435793

**Brief Title:** Expiratory Pressure in Healthy Individuals

**Official Title:** Determining Factors of the Maximal Expiratory Pressure in Healthy Individuals: Influence of the Mouthpiece Configuration

#### Organization Study ID Info
**ID:** P2024/081
#### Organization
**Class:** OTHER
**Full Name:** Laboratory of Movement, Condorcet, Tournai, Belgium
### Status Module
#### Completion Date
**Date:** 2025-09-18

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-26

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-18

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Mons

#### Lead Sponsor

**Class:** OTHER

**Name:** Laboratory of Movement, Condorcet, Tournai, Belgium

#### Responsible Party

**Investigator Affiliation:** University of Mons

**Investigator Full Name:** Dr F Duprez

**Investigator Title:** Physiotherapist / Professor at Provincial High School Condorcet (PhD)

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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 abdominal muscles).

Incidentally, it also aims at clarifying the role of orofacial muscles, if any, in the neuromuscular recruitment of the aforementioned 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.

### Conditions Module

**Conditions:**

- Respiratory Physiology

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: MEP measurement - Surface EMG - IOPI

**Label:** Healthy subjects

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Healthy subjects

**Description:** Participants will undergo serial expiratory maneuvers using variously-sized circular mouthpieces and a reference ovoid-shaped mouthpiece.

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.

The Orbicularis Oris strength will also be measured using the Iowa Oral Performance Instrument.

**Name:** MEP measurement - Surface EMG - IOPI

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Maximal expiratory pressure

**Time Frame:** 120 minutes

**Measure:** Root mean square of the EMG signal

**Time Frame:** 120 minutes

#### Secondary Outcomes

**Description:** 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

**Measure:** Orbicularis Oris Performance Index

**Time Frame:** 5 minutes

**Description:** Obtained through the Iowa Oral Performance Instrument

**Measure:** Orbicularis Oris strength

**Time Frame:** 10 minutes

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 535678@umons.ac.be

**Name:** Eliot Rudy Mbolo Ebubu (MD, PhD candidate)

**Phone:** 0032485114738

**Role:** CONTACT

**Contact 2:**

**Email:** frederic.duprez@condorcet.be

**Name:** Frederic Duprez (PhD)

**Phone:** 0032475857104

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** University of Mons

**Name:** Alexandre Legrand (MD, PhD)

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Provincial High School of Hainaut, Condorcet

**Name:** Frederic Duprez (PhD)

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** University of Mons

**Name:** Eliot Rudy Mbolo Ebubu (MD, PhD candidate)

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
