Obesity & Overweight, Obstructive Sleep Apnea (OSA), Pediatric Obesity
Conditions
Keywords
Tongue ultrasound, Shear-wave elastography, Pediatric obesity, Obstructive sleep apnea
Brief summary
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.
Detailed description
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. Ultrasound 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.
Interventions
OTHERSubmental ultrasound
Tongue ultrasound via a submental approach. This non-invasive, risk-free and harmless protocol will study both morphological and dynamic characteristics of the tongue.
Sponsors
Haute Ecole Bruxelles-Brabant
Vrije Universiteit Brussel
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Children and adolescents aged 6 to 18 years * Diagnosis of obesity * Already enrolled in the inpatient weight-loss rehabilitation program at the Zeepreventorium * Written informed consent from legal guardian and assent from the participant, following the legal requirements
Exclusion criteria
* Known orthopedic, traumatic, or rheumatologic conditions affecting the cervicocephalic region * Contraindication to ultrasound examination * Inability to comply with study procedures * Inability to understand the procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tongue stiffness | at baseline and after 30-weeks weight loss program | Tongue stiffness is measured by shear-wave elastography and expressed in kPa. |
| Intraclass correlation coefficient, ICC | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Tissue Attenuation Imaging index | 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. |
| OSA-18 questionnaire | Baseline and after a 30-weeks weight loss program | 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. |
| Weight | baseline and after a 30 weeks weight loss program | Weight will be measured with a Tanita scale and expressed in kg |
| Height | Baseline and after a 30 weeks weight loss program | Height will be measured with a stadiometer and expressed in cm |
| BMI Z score | Baseline and after a 30-weeks weight loss program | BMI Z score will be calculated using combined weight, heigt, sex and age, in reference with CDC tables |
Countries
Belgium
Contacts
CONTACTFrederic Paillaugue, MSc PT
STUDY_DIRECTORSteven Provyn, Prof PhD
Haute Ecole Bruxelles Brabant & Vrije Universiteit Brussel
Outcome results
None listed