Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-30 @ 11:58 AM
Study NCT ID:
NCT06169761
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2023-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tongue Protrusion Assessment in Healthy Adult (FLEPI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012306', 'term': 'Risk'}], 'ancestors': [{'id': 'D011336', 'term': 'Probability'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tongue protrusion peak pressure', 'timeFrame': 'Measured two times: at baseline and after 2 to 4 weeks', 'description': 'Tongue peak pressure during protrusion movements will be measured via the IOPI device'}, {'measure': 'Tongue protrusion endurance', 'timeFrame': 'Measured two times: at baseline and after 2 to 4 weeks', 'description': 'Tongue endurance during protrusion movements will be measured via a timer (the time in seconds until the participant is not able to sustain tongue protrusion as controlled via the IOPI).'}], 'secondaryOutcomes': [{'measure': 'Tongue elevation peak pressure', 'timeFrame': 'Measured two times: at baseline and after 2 to 4 weeks', 'description': 'Tongue peak pressure during elevation movements will be measured via the IOPI device'}, {'measure': 'Tongue elevation endurance', 'timeFrame': 'Measured two times: at baseline and after 2 to 4 weeks', 'description': 'will be measured via a timer (the time in seconds until the participant is not able to sustain tongue protrusion as controlled via the IOPI).'}, {'measure': 'Tongue mobility restriction', 'timeFrame': 'Measured once at baseline', 'description': 'Assessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate, measured with the Quick Tongue-Tie Assessment Tool'}, {'measure': 'Maximum Inspiratory and Expiratory Pressure', 'timeFrame': 'Measured once at baseline', 'description': 'Maximum Inspiratory and Expiratory pressure will be measured via the MicroRPM device'}, {'measure': 'Handgrip Strength', 'timeFrame': 'Measured once at baseline', 'description': 'Handgrip Strength will be measured with a JAMAR Hand Dynamometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tongue', 'Motor skills', 'Protrusion', 'Strength', 'Fatigability'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate tongue protrusion motor skills in healthy adults and to assess the reliability of these measurements as well as their validity in relation to other motor functions (handgrip and respiratory muscles).', 'detailedDescription': 'The tongue is an organ involved in multiple essential daily functions (such as eating, speaking, and breathing). Normative values exist for the motor skills of tongue elevation in individuals. However, data regarding protrusion are lacking. Yet, the protrusive strength of the tongue is of particular interest. Indeed a weak protrusive tongue strength may contribute to sleep apnea and swallowing disorders. Therefore, this study aims to collect normative and clinimetric (validity and reliability) data of tongue protrusion strength and endurance among healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population comprised healthy adults from Belgium, including both men and women aged 18 years and older, who meet all eligibility criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 18 years of age or older\n\nExclusion Criteria:\n\n* Eating disorder\n* Dysphagia\n* Cardiorespiratory disorder\n* Previous or ongoing obstructive sleep apnea-hypopnea syndrome\n* Neurological conditions (including neuromuscular disorders)\n* Previous or ongoing cancer of the head or neck\n* Pregnancy\n* Any physical or mental condition that may affect the ability to consent'}, 'identificationModule': {'nctId': 'NCT06169761', 'briefTitle': 'Tongue Protrusion Assessment in Healthy Adult (FLEPI)', 'organization': {'class': 'OTHER', 'fullName': 'Université Catholique de Louvain'}, 'officialTitle': 'Assessment of Tongue Protrusion Motor Skills in Healthy Adult', 'orgStudyIdInfo': {'id': 'FLEPI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy adults', 'description': 'Healthy adults of 18 years and older will fill out the STOP-BANG Questionnaire and undergo protrusive motor skills measurements.', 'interventionNames': ['Other: Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apnea']}], 'interventions': [{'name': 'Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apnea', 'type': 'OTHER', 'description': 'The following items will be assessed:\n\n1. Risk for sleep apnea, through the STOP-BANG Questionnaire.\n2. Anthropometric data: Height, weight, neck circumference, maximal mouth opening and maximal mouth opening with tongue to palate (with the Quick Tongue-Tie Assessment tool).\n3. Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb in kPa) during 3 sec. of tongue protrusion and elevation.\n4. Tongue endurance (i.e., the time to task failure in maintaining a pressure equal to a fixed percentage of Pmax against the IOPI bulb) during tongue protrusion and elevation\n5. Tongue mobility restriction measured with the Quick Tongue-Tie Assessment Tool\n6. Maximum inspiratory and expiratory pressures measured with MicroRPM in cmH2O\n7. Handgrip strength (measured with a JAMAR dynamometer in kg)\n\nTongue skills measurements will be repeated 2 to 4 weeks after baseline to assess the reliability of these measurements.', 'armGroupLabels': ['Healthy adults']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Louvain-la-Neuve', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'William Poncin', 'role': 'CONTACT', 'email': 'william.poncin@uclouvain.be', 'phone': '0032 10 47 21 11'}], 'facility': 'UCLouvain', 'geoPoint': {'lat': 50.66829, 'lon': 4.61443}}], 'centralContacts': [{'name': 'William Poncin, PT, PhD', 'role': 'CONTACT', 'email': 'william.poncin@uclouvain.be', 'phone': '+3227641111'}, {'name': 'Julien Da Purificaçao, PT', 'role': 'CONTACT', 'email': 'dapurificacaojulien.kine@uclouvain.be', 'phone': '+33788734941'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'William Poncin', 'investigatorAffiliation': 'Université Catholique de Louvain'}}}}