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Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disorders

21 mai 2026 mis à jour par: Vrije Universiteit Brussel

Standardised Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disordered Breathing: a Research Protocol

Obstructive sleep-disordered breathing, including obstructive sleep apnea (OSA), represents a significant yet underdiagnosed condition in the pediatric population, particularly among adolescents with obesity. The tongue is a central anatomical contributor to upper airway collapsibility; however, its biomechanical properties have been investigated almost exclusively in adult populations, leaving a critical gap in knowledge regarding younger individuals.

This study aims to assess tongue biomechanical and echographic characteristics using quantitative ultrasound modalities - shear-wave elastography (SWE), acoustic attenuation, and echo intensity - in adolescents aged 12 to 18 years with obesity and obstructive sleep disorders. The study adopts a mixed design combining (1) an observational cross-sectional comparison between participants with obesity and OSDB and age- and sex-matched healthy controls at baseline, and (2) a prospective longitudinal cohort component evaluating changes in tongue ultrasound characteristics over the course of a 30-week multidisciplinary inpatient weight-loss program delivered as standard care at the Zeepreventorium (De Haan, Belgium). An additionnal methodological objective consists in determining intra-rater and inter-rater reliability of the ultrasound acquisition protocol providing a reproducible framework for future studies.

Aperçu de l'étude

Description détaillée

Scientific Background and Rationale Amongst obstructive sleep disorders, Obstructive sleep apnea (OSA) is characterized by repetitive complete (apnea) or partial (hypopnea) collapse of the upper airway during sleep. Upper airway collapsibility in OSA results from the interaction of multiple contributing mechanisms, including craniofacial morphology (retrognathia, maxillary constriction, reduced posterior airway space), adenotonsillar hypertrophy - a predominant anatomical risk factor in the pediatric population -, obesity-related peripharyngeal fat deposition, neuromuscular control deficits of upper airway dilator muscles, and environmental exposures such as prenatal or passive tobacco smoke exposure, associated with increased upper airway inflammation and altered respiratory control.

Among the anatomical structures implicated in upper airway collapsibility, the tongue plays a central role as the largest muscular structure of the oropharynx. Morphological and biomechanical alterations (incl. increased volume, fat infiltration at the base, posterior positioning, and modified tissue stiffness) have been identified as relevant contributors to airway obstruction and are increasingly investigated as potential screening markers.

In the pediatric population, OSA remains substantially underdiagnosed. Access to polysomnography is limited, parents seldom spontaneously report nocturnal symptoms, and prevalence estimates vary widely in the literature (1.2% to over 60% in children with obesity), partly due to heterogeneous diagnostic criteria. This epidemiological uncertainty underscores the need for accessible, non-invasive tools capable of characterizing tongue biomechanical properties in younger populations - a gap that the present study directly addresses.

Ultrasound is non-invasive, non-ionizing, widely accessible, and well tolerated, including in adolescents. Existing studies applying these modalities to the tongue in OSA have been conducted exclusively in adult populations and report heterogeneous, sometimes contradictory findings. Methodological variability in acquisition parameters, probe positioning, and region-of-interest definition substantially limits reproducibility and inter-study comparability. No study to date has applied this multimodal quantitative ultrasound approach to adolescents with obesity and obstructive sleep-disordered breathing, nor examined the longitudinal trajectory of these parameters in response to a structured weight-loss intervention. The present study is therefore the first to address this population and this clinical question.

Tongue morphology and tongue fat in patients suffering from OSA have been assessed several times with ultrasound, a non-invasive, widely accessible imaging modality that provides real-time visualization of tissues and is generally well tolerated, with minimal to no associated discomfort. Ultrasound echo intensity has been validated with MRI to estimate tongue fat percentage. Advanced ultrasound modalities, such as shear wave elastography (SWE) and attenuation imaging (AI), provide quantitative measures of tissue stiffness and its attenuation properties, respectively Existing studies on tongue SWE and echo intensity (EI) have been conducted exclusively in adults and report heterogeneous, and sometimes contradictory, findings in patients suffering from OSA. Raw data in EI values would increase in the case of high lipidic impregnation or fibrous accumulation and decrease when the amount of muscle is higher, but the results are still variable depending on the location. Methodological variability in acquisition parameters, probe positioning, region-of-interest definition, and data analysis substantially limit reproducibility and comparability. Arbitrary region-of-interest sizing that does not account for individual tongue morphology may further introduce systematic bias.

Another gap in current research is the limited focus on younger populations. While studies have primarily targeted middle-aged and older adults due to the higher prevalence of OSA in these groups, the biomechanical properties of the tongue may differ significantly in younger individuals, due to growth and hormonal factors. In particular, heterogeneous distribution of elasticity values between anterior and posterior regions of the tongue indicate that there is a need for a better understanding The objectives of this study and anticipated new evidence are as follows below. Primary objective: to compare tongue biomechanical properties, assessed using shear-wave elastography and quantitative ultrasound, between children and adolescents with obesity and obstructive sleep disorders and age-matched healthy controls.

Secondary objectives: (1) to assess longitudinal changes in tongue echographic characteristics over the course of a 30-week multidisciplinary weight-loss program delivered as part of standard care and (2) to evaluate the influence of anthropometric parameters, sex, and pubertal status on these measurements.

Methodological objective: to determine the intra-rater and inter-rater reliability of ultrasound-based tongue measurements, thereby providing a reproducible framework for future clinical and comparative studies.

Type d'étude

Interventionnel

Inscription (Estimé)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

      • Brussels, Belgique, 1090
        • KidZ Health Castle - Universitair Ziekenhuis Brussel Brussels - Health Campus Avenue du Laerbeek 101 1090 Jette
        • Contact:
        • Contact:
        • Chercheur principal:
          • Steven Provyn, Prof PhD
      • De Haan, Belgique, 8420
        • Zeepreventorium, Koninklijke Baan 5, 8420 De Haan
        • Contact:
          • Frederic Paillaugue, MSc PT
          • Numéro de téléphone: +32485952930
        • Chercheur principal:
          • Steven Provyn, Prof PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • Aged 12-18 years
  • Already enrolled in Zeepreventorium weight-loss program as Standard Care Diagnosed Obstructive Sleep Apnea (AHI ≥ 1)1 or any Obstructive sleep disordered breathing detected by any of the specific sleep questionnaire (OSA-18, ESS, SSS-Ad, PDSS)

Exclusion Criteria:

  • Any other orthopedic, traumatic, or rheumatologic condition affecting the cervicocephalic region
  • Syndromic or neuromuscular disorders
  • Cognitive impairment limiting compliance with study procedures
  • Inability to provide informed consent
  • Self-reported alcohol or recreational drug consumption within 48 hours preceding the experimental session

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Study group

Adolescents (12-18 y.o.) with obesity and sleep-disordered breathing, recruited at the Zeepreventorium de Haan and at the KidZ Health Castle UZ-VUB.

The intervention will consist of a submental ultrasound examination - a pain-free, non-ionizing, and non-invasive imaging procedure - aimed at quantifying tongue biomechanical properties, complemented by the collection of descriptive and anthropometric measures including standing height, body weight, impedance analysis, and neck circumference.

Tongue ultrasound via a submental approach. This non-invasive, pain-free and non-radiating protocol will study both morphological and dynamic characteristics of the tongue. Ultrasonographic assessment will be performed with participants in a resting, supine position and ultrasound gel will be used to optimise submental probe contact.
Comparateur actif: Control group
A control group of healthy participants (without obesity nor sleep disorders), matched for gender and age, will be recruited from among the researchers' acquaintances. The intervention will be the same, consisting of a submental ultrasound examination - a pain-free, non-ionizing, and non-invasive imaging procedure - aimed at quantifying tongue biomechanical properties, complemented by the collection of descriptive and anthropometric measures including standing height, body weight, impedance analysis, and neck circumference.
Tongue ultrasound via a submental approach. This non-invasive, pain-free and non-radiating protocol will study both morphological and dynamic characteristics of the tongue. Ultrasonographic assessment will be performed with participants in a resting, supine position and ultrasound gel will be used to optimise submental probe contact.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Raideur de la langue
Délai: au départ et après un programme de perte de poids de 30 semaines
La rigidité de la langue est mesurée par élastographie par ondes de cisaillement et exprimée en kPa.
au départ et après un programme de perte de poids de 30 semaines
Épaisseur de la langue
Délai: au départ et après 30 semaines de programme de perte de poids
L'épaisseur de la langue (exprimée en cm) sera mesurée par échographie comme la distance perpendiculaire entre le fascia profond du muscle génio-hyoïdien et le point le plus élevé du dos de la langue dans le plan médio-sagittal
au départ et après 30 semaines de programme de perte de poids
Intensité de l'écho
Délai: au départ et après un programme de perte de poids de 30 semaines
L'intensité d'écho sera mesurée avec le logiciel ImageJ / Fiji (ImageJ, US NIH, Bethesda, États-Unis) et correspond à la valeur moyenne des pixels d'une zone, sur une échelle de gris comprise entre 0 (noir) et 255 (blanc).
au départ et après un programme de perte de poids de 30 semaines
Acoustic Attenuation
Délai: at baseline and after a 30 weeks weight loss program
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.
at baseline and after a 30 weeks weight loss program

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Coefficient de corrélation intraclasse, CCI
Délai: Baseline
Le coefficient de corrélation intraclasse sera utilisé pour évaluer la fiabilité intra et inter-évaluateurs des marqueurs échographiques. La fiabilité et la reproductibilité échographiques des mesures de la langue seront évaluées avec des coefficients de corrélation intraclasse (CCI), ainsi que leurs intervalles de confiance à 95 %. Chaque mesure échographique (taille de la langue et paramètres morphologiques, intensité d'écho, rigidité, imagerie d'atténuation tissulaire, imagerie de distribution de la diffusion tissulaire et fraction de graisse) dans les plans sagittal et coronal sera réalisée deux fois chez quinze participants par l'investigateur principal, avec un intervalle de 24 heures entre les examens.
Baseline
Poids
Délai: ligne de base et après un programme de perte de poids de 30 semaines
Le poids sera mesuré avec une balance Tanita et exprimé en kg
ligne de base et après un programme de perte de poids de 30 semaines
Hauteur
Délai: Baseline et après un programme de perte de poids de 30 semaines
La taille sera mesurée avec un stadiomètre et exprimée en cm
Baseline et après un programme de perte de poids de 30 semaines
OSA-18 questionnaire
Délai: Baseline and after a 30-weeks weight loss program

The OSA-18 is a disease-specific screening tool for early diagnosis of obstructive sleep apnea in children, and is used to evaluate the quality of life before and after treatment.

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.

Baseline and after a 30-weeks weight loss program
Stanford Sleepiness Scale (for adolescents)
Délai: Baseline and after a 30-weeks weight loss program
The Stanford Sleepiness Scale (SSS) is a single-item, momentary self-report scale assessing current level of alertness and sleepiness on a 7-point ordinal scale, ranging from 1 ("feeling active, vital, alert, or wide awake") to 7 ("no longer fighting sleep, sleep onset soon, having dream-like thoughts"). Originally developed by Hoddes et al. (1973), the scale captures state sleepiness at a given moment rather than habitual sleepiness patterns, making it particularly suitable for repeated within-session assessments. Its adaptation and use in adolescent populations has been documented in pediatric sleep research, where it complements trait-level instruments such as the ESS and PDSS.
Baseline and after a 30-weeks weight loss program
Pediatric Daytime Sleepiness Scale (PDSS)
Délai: Baseline and after a 30-weeks weight loss program
The Pediatric Daytime Sleepiness Scale (PDSS) is an 8-item self-report questionnaire designed to assess daytime sleepiness in school-aged children and adolescents. Each item is rated on a 5-point Likert scale (0-4), yielding a total score ranging from 0 to 32, with higher scores indicating greater daytime sleepiness. The PDSS was developed and validated by Drake et al. (2003) and has demonstrated adequate internal consistency (Cronbach's α = 0.78) and convergent validity with objective sleep measures. It is specifically designed for pediatric populations and captures sleep-related daytime impairment across academic, behavioral, and social domains. A score ≥ 15 has been proposed as a clinically meaningful threshold for excessive daytime sleepiness in adolescents.
Baseline and after a 30-weeks weight loss program
Epworth Sleepiness Scale (ESS)
Délai: Baseline and after a 30-weeks weight loss program
The Epworth Sleepiness Scale (ESS) is an 8-item self-report questionnaire assessing the propensity to fall asleep across eight everyday situations, rated on a 4-point Likert scale (0-3), yielding a total score ranging from 0 to 24. Higher scores reflect greater subjective daytime sleepiness. Originally developed and validated by Johns (1991) in adults, the ESS has been subsequently validated for use in adolescent populations and is among the most widely used instruments for screening excessive daytime sleepiness in clinical and research settings. A score > 10 is conventionally considered indicative of excessive daytime sleepiness.
Baseline and after a 30-weeks weight loss program
BMI Z-score
Délai: Baseline and after a 30-weeks weight loss program
The body mass index Z-score (BMI Z-score, also referred to as BMI standard deviation score) is a age- and sex-standardized measure of body mass index (BMI, kg/m²) that expresses an individual's BMI relative to a reference population of the same age and sex. It is calculated as the deviation of an individual's BMI from the median BMI of the reference population, expressed in units of standard deviation. In pediatric populations, the BMI Z-score is the recommended metric for assessing adiposity and defining weight status categories, as raw BMI values are not directly comparable across age and sex groups due to physiological changes in body composition during growth. In the present study, BMI Z-scores will be calculated according to the World Health Organization (WHO) 2007 reference data for school-aged children and adolescents (5-19 years). Obesity is defined as a BMI Z-score > +2 SD, and overweight as a BMI Z-score between +1 SD and +2 SD above the age- and sex-specific median.
Baseline and after a 30-weeks weight loss program

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

  • 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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 septembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

21 mai 2026

Première soumission répondant aux critères de contrôle qualité

21 mai 2026

Première publication (Réel)

29 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

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INDÉCIS

Description du régime IPD

Individual participant data (IPD) may not be shared publicly, given the sensitive nature of the data collected (health data from minors) and the applicable data protection requirements under the General Data Protection Regulation (GDPR, EU 2016/679). Pseudonymized data will be stored on the secure VUB research data platform (Pixiu) and accessible only to authorized members of the research team. Aggregate and summary data supporting the findings of this study will be made available upon reasonable request to the corresponding author, subject to ethical and institutional approval.

Informations sur les médicaments et les dispositifs, documents d'étude

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Non

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Non

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