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

Condition(s) studied

Investigational drug(s) / intervention(s)

Submental ultrasound: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Tongue stiffness — at baseline and after 30-weeks weight loss program
  Tongue stiffness is measured by shear-wave elastography and expressed in kPa.
• Tongue thickness — 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
• Echo Intensity — 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)
• Acoustic Attenuation — 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.

Trial sites (2)

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