Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT06435793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expiratory Pressure in Healthy Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-26', 'studyFirstSubmitDate': '2024-05-26', 'studyFirstSubmitQcDate': '2024-05-26', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal expiratory pressure', 'timeFrame': '120 minutes'}, {'measure': 'Root mean square of the EMG signal', 'timeFrame': '120 minutes'}], 'secondaryOutcomes': [{'measure': 'Orbicularis Oris Performance Index', 'timeFrame': '5 minutes', '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 strength', 'timeFrame': '10 minutes', 'description': 'Obtained through the Iowa Oral Performance Instrument'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Physiology']}, 'descriptionModule': {'briefSummary': '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).\n\nIncidentally, it also aims at clarifying the role of orofacial muscles, if any, in the neuromuscular recruitment of the aforementioned muscles.', 'detailedDescription': '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\n\nMaximal Respiratory Mouth Pressures (MIP and MEP):\n\nMaximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) are commonly used indices to assess respiratory muscle strength at the mouth.\n\nMIP measures the strength of inspiratory muscles, while MEP assesses expiratory muscle strength.\n\nThese measurements are simple, convenient, and noninvasive. However, clear standards for these measurements are not well-established.\n\nChoice of Mouthpiece:\n\nWe propose exploring different mouthpiece designs to know their impact on pressure measurements.\n\nInfluence of Mouthpiece Design:\n\nThe 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.\n\nHowever, 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.\n\nAdditional Considerations:\n\nFactors like body position (sitting vs. half-lying) may also impact pressure measurements, although no significant differences were found in one study.\n\nAmong the objectives of our study, we aim at exploring ways to improve the accuracy and reliability of respiratory pressure measurements.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18\n\nExclusion Criteria:\n\n* Any neuromuscular disease or condition susceptible to interfere with the results\n* Pregnant women\n* Any contraindications to the realization of maximal expiratory maneuvers, as defined in the ATS Pulmonary Function Laboratory Management And Procedure Manual (3rd Edition)\n* Excessive abdominal gird, compromising ultrasonographic positioning of electrodes or altering signal quality'}, 'identificationModule': {'nctId': 'NCT06435793', 'briefTitle': 'Expiratory Pressure in Healthy Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Laboratory of Movement, Condorcet, Tournai, Belgium'}, 'officialTitle': 'Determining Factors of the Maximal Expiratory Pressure in Healthy Individuals: Influence of the Mouthpiece Configuration', 'orgStudyIdInfo': {'id': 'P2024/081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy subjects', 'interventionNames': ['Procedure: MEP measurement - Surface EMG - IOPI']}], 'interventions': [{'name': 'MEP measurement - Surface EMG - IOPI', 'type': 'PROCEDURE', 'description': 'Participants will undergo serial expiratory maneuvers using variously-sized circular mouthpieces and a reference ovoid-shaped mouthpiece.\n\nAt 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.\n\nThe Orbicularis Oris strength will also be measured using the Iowa Oral Performance Instrument.', 'armGroupLabels': ['Healthy subjects']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eliot Rudy Mbolo Ebubu (MD, PhD candidate)', 'role': 'CONTACT', 'email': '535678@umons.ac.be', 'phone': '0032485114738'}, {'name': 'Frederic Duprez (PhD)', 'role': 'CONTACT', 'email': 'frederic.duprez@condorcet.be', 'phone': '0032475857104'}], 'overallOfficials': [{'name': 'Alexandre Legrand (MD, PhD)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Mons'}, {'name': 'Frederic Duprez (PhD)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Provincial High School of Hainaut, Condorcet'}, {'name': 'Eliot Rudy Mbolo Ebubu (MD, PhD candidate)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Mons'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratory of Movement, Condorcet, Tournai, Belgium', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Mons', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist / Professor at Provincial High School Condorcet (PhD)', 'investigatorFullName': 'Dr F Duprez', 'investigatorAffiliation': 'University of Mons'}}}}