NCT06435793

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 18, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

May 26, 2024

Last Update Submit

February 23, 2026

Conditions

Respiratory Physiology

Outcome Measures

Primary Outcomes (2)

  • Maximal expiratory pressure

    120 minutes

  • Root mean square of the EMG signal

    120 minutes

Study Arms (1)

Healthy subjects

EXPERIMENTAL
Other: MEP measurement - Surface EMG

Interventions

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.

Healthy subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haute Ecole Provinciale du Hainaut Condorcet

Tournai, Belgium

Location

Study Officials

  • Alexandre Legrand (MD, PhD), Physician, PhD

    University of Mons

    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

  • Alexandra Tassin, Biomedical scientist

    University of Mons

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist / Professor at Provincial High School Condorcet (PhD)

Study Record Dates

First Submitted

May 26, 2024

First Posted

May 30, 2024

Study Start

September 18, 2024

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

BE(1)