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NCT Number: NCT07613944

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

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KidZ Health Castle - Universitair Ziekenhuis Brussel Brussels - Health Campus Avenue du Laerbeek 101 1090 Jette, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Submental ultrasound

Device

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.

Primary outcomes

  1. Tongue stiffness

    Time frame: at baseline and after 30-weeks weight loss program

    Tongue stiffness is measured by shear-wave elastography and expressed in kPa.

  2. Tongue thickness

    Time frame: at baseline and after 30 weeks weight loss program

    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

  3. Echo Intensity

    Time frame: at baseline and after a 30 weeks weight loss program

    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)

  4. Acoustic Attenuation

    Time frame: 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.

Secondary outcomes

  1. Intraclass correlation coefficient, ICC

    Time frame: Baseline

    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.

  2. OSA-18 questionnaire

    Time frame: 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.

  3. Stanford Sleepiness Scale (for adolescents)

    Time frame: 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.

  4. Pediatric Daytime Sleepiness Scale (PDSS)

    Time frame: 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.

  5. Epworth Sleepiness Scale (ESS)

    Time frame: 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.

  6. Weight

    Time frame: baseline and after a 30 weeks weight loss program

    Weight will be measured with a Tanita scale and expressed in kg

  7. Height

    Time frame: Baseline and after a 30 weeks weight loss program

    Height will be measured with a stadiometer and expressed in cm

  8. BMI Z-score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Frederic Paillaugue, MSc PT

CONTACT

[email protected]

+32485952930

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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