Ultrasound Assessment of Tongue Characteristics in Children and Adolescents With Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorHaute Ecole Bruxelles-Brabant
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Children and adolescents with obesity participating in a specialized inpatient multidisciplinary weight-loss rehabilitation program in Zeepreventorium de Haan.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Submental ultrasound
Other interventionTongue ultrasound via a submental approach. This non-invasive, risk-free and harmless protocol will study both morphological and dynamic characteristics of the tongue.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Study group1 intervention
Group B: Control group1 intervention
Trial outcomes
Primary outcomes
1
Tongue stiffness
Tongue stiffness is measured by shear-wave elastography and expressed in kPa.
Time frame
at baseline and after 30-weeks weight loss program2
Intraclass correlation coefficient, ICC
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.
Time frame
BaselineSecondary outcomes
1
Tongue thickness
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
Time frame
at baseline and after 30 weeks weight loss program2
Echo Intensity
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)
Time frame
at baseline and after a 30 weeks weight loss program3
Tissue Attenuation Imaging index
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.
Time frame
at baseline and after a 30 weeks weight loss program4
OSA-18 questionnaire
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.
Time frame
Baseline and after a 30-weeks weight loss programSponsors and contacts
Click on the lead sponsor to view all of their trials.
Haute Ecole Bruxelles-Brabant
Lead sponsor
Vrije Universiteit Brussel
Collaborator
Source ClinicalTrials.gov