- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07613944
Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disorders
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Frederic Paillaugue, MSc PT
- Numer telefonu: +32485952930
- E-mail: frederic.paillaugue@vub.be
Lokalizacje studiów
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Brussels, Belgia, 1090
- KidZ Health Castle - Universitair Ziekenhuis Brussel Brussels - Health Campus Avenue du Laerbeek 101 1090 Jette
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Kontakt:
- Frederic Paillaugue, MSc PT
- Numer telefonu: +32485952930
- E-mail: frederic.paillaugue@vub.be
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Kontakt:
- Inge Gies, MD
- Numer telefonu: +324774111
- E-mail: inge.gies@uzbrussel.be
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Główny śledczy:
- Steven Provyn, Prof PhD
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De Haan, Belgia, 8420
- Zeepreventorium, Koninklijke Baan 5, 8420 De Haan
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Kontakt:
- Frederic Paillaugue, MSc PT
- Numer telefonu: +32485952930
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Główny śledczy:
- Steven Provyn, Prof PhD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Nielosowe
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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Aktywny komparator: 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Sztywność języka
Ramy czasowe: na początku i po 30-tygodniowym programie odchudzania
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Sztywność języka jest mierzona za pomocą elastografii fali ścinającej i wyrażana w kPa.
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na początku i po 30-tygodniowym programie odchudzania
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Grubość języka
Ramy czasowe: na początku badania i po 30 tygodniach programu odchudzającego
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Grubość języka (wyrażona w cm) będzie mierzona za pomocą ultrasonografii jako odległość prostopadła od głębokiej powięzi mięśnia bródkowo-gnykowego do najwyższego grzbietu języka w płaszczyźnie pośrodkowej
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na początku badania i po 30 tygodniach programu odchudzającego
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Intensywność Echa
Ramy czasowe: na początku oraz po 30-tygodniowym programie odchudzania
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Intensywność echa będzie mierzona za pomocą oprogramowania ImageJ / Fiji (ImageJ, US NIH, Bethesda, USA) i odnosi się do średniej wartości pikseli obszaru, opartej na skali szarości między 0 (czarny) a 255 (biały)
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na początku oraz po 30-tygodniowym programie odchudzania
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Acoustic Attenuation
Ramy czasowe: at baseline and after a 30 weeks weight loss program
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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.
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at baseline and after a 30 weeks weight loss program
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Współczynnik korelacji wewnątrzklasowej, ICC
Ramy czasowe: Wartość wyjściowa
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Współczynnik korelacji wewnątrzklasowej zostanie zastosowany do oceny wiarygodności wewnątrz- i międzyobserwatorowej markerów ultrasonograficznych. Wiarygodność i powtarzalność pomiarów ultrasonograficznych języka zostanie oceniona za pomocą współczynników korelacji wewnątrzklasowej (ICC) wraz z ich 95% przedziałami ufności.
Każdy pomiar ultrasonograficzny (wielkość języka i parametry morfologiczne, intensywność echa, sztywność, obrazowanie tłumienia tkanek, obrazowanie rozkładu rozproszenia tkanek oraz frakcja tłuszczu) w płaszczyznach strzałkowej i wieńcowej zostanie wykonany dwukrotnie u piętnastu uczestników przez głównego badacza, z 24-godzinnym odstępem między badaniami.
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Wartość wyjściowa
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Masa ciała
Ramy czasowe: linia bazowa i po 30-tygodniowym programie redukcji masy ciała
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Wagę zmierzy się za pomocą wagi Tanita i wyrazi w kg
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linia bazowa i po 30-tygodniowym programie redukcji masy ciała
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Wysokość
Ramy czasowe: Wartości wyjściowe i po 30-tygodniowym programie redukcji masy ciała
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Wysokość będzie mierzona za pomocą stadiometru i wyrażana w cm
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Wartości wyjściowe i po 30-tygodniowym programie redukcji masy ciała
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OSA-18 questionnaire
Ramy czasowe: Baseline and after a 30-weeks weight loss program
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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
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Stanford Sleepiness Scale (for adolescents)
Ramy czasowe: Baseline and after a 30-weeks weight loss program
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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.
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Baseline and after a 30-weeks weight loss program
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Pediatric Daytime Sleepiness Scale (PDSS)
Ramy czasowe: Baseline and after a 30-weeks weight loss program
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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.
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Baseline and after a 30-weeks weight loss program
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Epworth Sleepiness Scale (ESS)
Ramy czasowe: Baseline and after a 30-weeks weight loss program
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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.
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Baseline and after a 30-weeks weight loss program
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BMI Z-score
Ramy czasowe: Baseline and after a 30-weeks weight loss program
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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.
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Baseline and after a 30-weeks weight loss program
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- 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
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 26137_EchoTongue
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
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