Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:47 AM
Study NCT ID:
NCT07370350
Status:
RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Assessment of Tongue Characteristics in Children and Adolescents With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001827', 'term': 'Body Height'}, {'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D049628', 'term': 'Body Size'}, {'id': 'D001837', 'term': 'Body Weights and Measures'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000067029', 'term': 'Physical Appearance, Body'}, {'id': 'D000886', 'term': 'Anthropometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006128', 'term': 'Growth'}, {'id': 'D048788', 'term': 'Growth and Development'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-17', 'studyFirstSubmitDate': '2026-01-03', 'studyFirstSubmitQcDate': '2026-01-17', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tongue stiffness', 'timeFrame': 'at baseline and after 30-weeks weight loss program', 'description': 'Tongue stiffness is measured by shear-wave elastography and expressed in kPa.'}, {'measure': 'Intraclass correlation coefficient, ICC', 'timeFrame': 'Baseline', 'description': 'Intraclass correlation coefficient will be used to assess intra and inter-rater reliability of ultrasound markersUltrasound reliability and repeatability of tongue measurements will be assessed with intraclass correlation coefficients (ICC), along with their 95% confidence intervals. Each ultrasound measurement (tongue size and morphological parameters, echo intensity, stiffness, tissue attenuation imaging, tissue scatter distribution imaging, and fat fraction) in sagittal and coronal planes will be performed twice in fifteen participants by the principal investigator, with a 24-hour interval between examinations.'}], 'secondaryOutcomes': [{'measure': 'Tongue thickness', 'timeFrame': 'at baseline and after 30 weeks weight loss program', 'description': 'Tongue thickness (expressed in cm) will be measured with ultrasound as the perpendicular distance from the deep fascia of the geniohyoid muscle to the highest lingual dorsum in the midsagittal plane'}, {'measure': 'Echo Intensity', 'timeFrame': 'at baseline and after a 30 weeks weight loss program', 'description': 'Echo intensity will be measured with ImageJ / Fiji software (ImageJ, US NIH, Bethesda, USA) and refers to the mean value of pixels of an area, based on a grey scale between 0 (black) and 255 (white)'}, {'measure': 'Tissue Attenuation Imaging index', 'timeFrame': 'at baseline and after a 30 weeks weight loss program', 'description': 'Attenuation will be measured with ultrasound and depicts the quantitative measurement of ultrasound attenuation in tissues. It is expressed as an attenuation coefficient in dB/cm/MHz.'}, {'measure': 'OSA-18 questionnaire', 'timeFrame': 'Baseline and after a 30-weeks weight loss program', 'description': 'The Obstructive Sleep Apnea - 18 questionnaire is specific to obstructive sleep apnea in children and will be used for correlation analysis. Quality of life is assessed using the Obstructive Sleep Apnea - 18 Quality of Life Survey (OSA-18), a validated questionnaire comprising 18 items. Total scores range from 18 to 126, with higher scores indicating poorer quality of life and greater disease impact, and lower scores reflecting better outcomes.'}, {'measure': 'Weight', 'timeFrame': 'baseline and after a 30 weeks weight loss program', 'description': 'Weight will be measured with a Tanita scale and expressed in kg'}, {'measure': 'Height', 'timeFrame': 'Baseline and after a 30 weeks weight loss program', 'description': 'Height will be measured with a stadiometer and expressed in cm'}, {'measure': 'BMI Z score', 'timeFrame': 'Baseline and after a 30-weeks weight loss program', 'description': 'BMI Z score will be calculated using combined weight, heigt, sex and age, in reference with CDC tables'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tongue ultrasound', 'Shear-wave elastography', 'Pediatric obesity', 'Obstructive sleep apnea'], 'conditions': ['Obesity & Overweight', 'Pediatric Obesity', 'Obstructive Sleep Apnea (OSA)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Brockmann, P., & Gozal, D. (2022). Neurocognitive Consequences in Children with Sleep Disordered Breathing: Who Is at Risk? Children, 9(9), 1278. https://doi.org/10.3390/children9091278 Chu, C.-A., Chen, Y.-J., Chang, K.-V., Wu, W.-T., & Özçakar, L. (2021). Reliability of Sonoelastography Measurement of Tongue Muscles and Its Application on Obstructive Sleep Apnea. Frontiers in Physiology, 12, 654667. https://doi.org/10.3389/fphys.2021.654667 da Silva Gusmão Cardoso, T., Pompéia, S., & Miranda, M. C. (2018). Cognitive and behavioral effects of obstructive sleep apnea syndrome in children: A systematic literature review. Sleep Medicine, 46, 46-55. https://doi.org/10.1016/j.sleep.2017.12.020 Gipson, K., Lu, M., & Kinane, T. B. (2019). Sleep-Disordered Breathing in Children. Pediatrics in Review, 40(1), 3-13. https://doi.org/10.1542/pir.2018-0142 Glicksman, A., Hadjiyannakis, S., Barrowman, N., Walker, S., Hoey, L., & Katz, S. L. (2017). Body Fat Distribution Ratios and Obstructive Sleep Apnea Severity in Youth With Obesity. Journal of Clinical Sleep Medicine: JCSM: Official Publication of the American Academy of Sleep Medicine, 13(4), 545-550. https://doi.org/10.5664/jcsm.6538 Halbower, A. C., Degaonkar, M., Barker, P. B., Earley, C. J., Marcus, C. L., Smith, P. L., Prahme, M. C., & Mahone, E. M. (2006). Childhood Obstructive Sleep Apnea Associates with Neuropsychological Deficits and Neuronal Brain Injury. PLoS Medicine, 3(8), e301. https://doi.org/10.1371/journal.pmed.0030301 Yu, J. L., Wiemken, A., Schultz, S. M., Keenan, B. T., Sehgal, C. M., & Schwab, R. J. (2022). A comparison of ultrasound echo intensity to magnetic resonance imaging as a metric for tongue fat evaluation. Sleep, 45(2), zsab295. https://doi.org/10.1093/sleep/zsab295'}]}, 'descriptionModule': {'briefSummary': 'This longitudinal observational study aims to validate ultrasound-based tongue markers related to tongue characteristics, including fat accumulation, morphologic and mechanical properties of the tongue in children and adolescents with obesity. Participants are assessed at baseline and after completion of a standardized 30-week inpatient weight-loss rehabilitation program at the Zeepreventorium (De Haan, Belgium). Tongue ultrasound parameters are examined in relation to anthropometric characteristics and obstructive sleep apnea condition.', 'detailedDescription': 'This prospective observational cohort study investigates ultrasound-based tongue characteristics in children and adolescents with obesity. Participants undergo standardized submental tongue ultrasound examinations at baseline and after completion of a 30-week inpatient multidisciplinary weight-loss rehabilitation program.\n\nUltrasound measures include tongue morphology, fat-related imaging biomarkers, and mechanical properties assessed using shear-wave elastography. Anthropometric data and validated sleep-disordered breathing questionnaires are collected in parallel. Measurement reliability is evaluated, and associations between ultrasound parameters, anthropometric characteristics, and sleep-related outcomes are explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolescents with obesity participating in a specialized inpatient multidisciplinary weight-loss rehabilitation program in Zeepreventorium de Haan.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and adolescents aged 6 to 18 years\n* Diagnosis of obesity\n* Already enrolled in the inpatient weight-loss rehabilitation program at the Zeepreventorium\n* Written informed consent from legal guardian and assent from the participant, following the legal requirements\n\nExclusion Criteria:\n\n* Known orthopedic, traumatic, or rheumatologic conditions affecting the cervicocephalic region\n* Contraindication to ultrasound examination\n* Inability to comply with study procedures\n* Inability to understand the procedures'}, 'identificationModule': {'nctId': 'NCT07370350', 'briefTitle': 'Ultrasound Assessment of Tongue Characteristics in Children and Adolescents With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Haute Ecole Bruxelles-Brabant'}, 'officialTitle': 'Standardized Tongue Ultrasound Protocol for Tongue Characteristics in Children and Adolescents With Obesity After a 30-week Inpatient Weight Loss Program', 'orgStudyIdInfo': {'id': '93018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Children and adolescents with obesity participating in a specialized inpatient multidisciplinary weight-loss rehabilitation program (30 weeks).\n\nAs this is an observational study, tongue ultrasound (via a submental approach, a non-invasive, risk-free and harmless procedure) will be performed and basic anthropometric data (height, weight, neck circumference, hydration status) will be collected.', 'interventionNames': ['Other: Submental ultrasound']}, {'label': 'Control group', 'description': 'Healthy children and adolescents. As this is an observational study, tongue ultrasound (via a submental approach, a non-invasive, risk-free and harmless procedure) will be performed and basic anthropometric data (height, weight, neck circumference, hydration status) will be collected.', 'interventionNames': ['Other: Submental ultrasound']}], 'interventions': [{'name': 'Submental ultrasound', 'type': 'OTHER', 'otherNames': ['Anthropometric measurements (height, weight, neck circumference)'], 'description': 'Tongue ultrasound via a submental approach. This non-invasive, risk-free and harmless protocol will study both morphological and dynamic characteristics of the tongue.', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1160', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Frederic Paillaugue, MSc PT', 'role': 'CONTACT', 'phone': '+32485952930'}], 'facility': 'ISEK-HE2B, av. Schalle 91', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'De Haan', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Steven Provyn, PhD', 'role': 'CONTACT', 'email': 'steven.provyn@vub.be', 'phone': '+32475454214'}], 'facility': 'Zeepreventorium Koninklijke Baan 5', 'geoPoint': {'lat': 51.27261, 'lon': 3.03446}}], 'centralContacts': [{'name': 'Frederic Paillaugue, MSc PT', 'role': 'CONTACT', 'email': 'frederic.paillaugue@vub.be', 'phone': '+32485952930'}], 'overallOfficials': [{'name': 'Steven Provyn, Prof PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Haute Ecole Bruxelles Brabant & Vrije Universiteit Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to the inclusion of minors and data protection regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haute Ecole Bruxelles-Brabant', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MSc PT Drs', 'investigatorFullName': 'Frédéric Paillaugue', 'investigatorAffiliation': 'Haute Ecole Bruxelles-Brabant'}}}}