Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
The tongue plays a key role in maintaining upper airway patency during sleep, mainly through the genioglossus, the principal pharyngeal dilator muscle. Its dysfunction may be linked to the development of obstructive sleep-disordered breathing (oSDB), a condition affecting more than one in ten children and associated with cardiovascular and cognitive consequences. Although adenotonsillectomy remains the treatment of choice, it fails in a substantial proportion of cases because of persistent obstruction at other sites, the tongue base being involved in one third of these cases. Therefore, a better characterization of the tongue in children with oSDB is needed, since the extent to which its structure and function contribute to upper airway obstruction in this population remains largely unknown.
Our team has established the reproducibility of tongue function measurements in healthy children and is currently building a reference database. What is still lacking is an assessment of tongue structure and function in children with oSDB. Such data would allow comparison with healthy children, thereby improving the understanding of oSDB pathophysiology and informing clinical management.
Primary objective: To describe tongue structure and function in children with oSDB.
Secondary objective: To compare tongue structure and function between children with oSDB and healthy children, using data from a previous study conducted in healthy children (TMAC study, UCLouvain).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: William Poncin, Professor
- Numéro de téléphone: 0471 90 66 23
- E-mail: william.poncin@uclouvain.be
Lieux d'étude
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Liège, Belgique, 4000
- Recrutement
- CHC MontLégia hospital
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Contact:
- Matthieu Thimmesch, MD
- Numéro de téléphone: 0032 4 355 50 20
- E-mail: Matthieu.THIMMESCH@chc.be
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Children with obstructive sleep-disordered breathing, with a scheduled polysomnography or who received a polysomnography within the past 6 months, and without any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III
La description
Inclusion Criteria:
- Aged 4 to 17 years
- Scheduled polysomnography, or polysomnography performed within the past 6 months
- Positive Pediatric Sleep Questionnaire (8 "yes" answers or more)
Exclusion Criteria:
- Any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III
- Any condition that could interfere with the assessments
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_CONTROL
- Perspectives temporelles: CROSS_SECTIONAL
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Unique arm, cross-sectional assessment
Single assessment visit |
This cross-sectional assessment includes outcomes related to tongue structure, tongue function, and questionnaires |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Tongue strength assessment
Délai: At enrollment, during the single study visit (Day 1)
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Maximal pressure exerted by the tongue against an air-filled bulb (in kPa) in protrusion, elevation, and during swallowing. |
At enrollment, during the single study visit (Day 1)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Tongue morphology assessment
Délai: At enrollment, during the single study visit (Day 1)
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Submental ultrasound in frontal and sagittal plane, to assess the thickness of tongue muscles (cm) |
At enrollment, during the single study visit (Day 1)
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Tongue frenulum assessment
Délai: At enrollment, during the single study visit (Day 1)
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Tongue range of motion ratio, reflecting the restriction imposed by the lingual frenulum. It is computed as the maximal mouth opening with the tongue tip held at the incisive papilla (mm) divided by the maximal mouth opening (mm). |
At enrollment, during the single study visit (Day 1)
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Tongue mobility score
Délai: At enrollment, during the single study visit (Day 1)
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Motricité Bucco-Linguo-Faciale (MBLF) test, where several movements are scored between 0 and 3 regarding muscular contraction or symmetry. |
At enrollment, during the single study visit (Day 1)
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Obstructive apnea-hypopnea index
Délai: At enrollment, during the single study visit (Day 1)
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Number of obstructive apneas and hypopneas per hour of sleep (events/hour) assessed through polysomnography |
At enrollment, during the single study visit (Day 1)
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Breathing pattern questionnaire
Délai: At enrollment, during the single study visit (Day 1)
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Mouth breathing questionnaire from Abreu et al., considered positive if two major items, or one major and two minor items, are answered "yes" |
At enrollment, during the single study visit (Day 1)
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Quality of life questionnaire
Délai: At enrollment, during the single study visit (Day 1)
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PedsQL questionnaire (Pediatric Quality of Life Inventory), divided into parent report and child self-report questionnaires, with several items scored from 0 to 4. Higher scores indicate more problems related to the quality of life. |
At enrollment, during the single study visit (Day 1)
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Sleep quality questionnaire
Délai: At enrollment, during the single study visit (Day 1)
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The Pediatric Sleep Questionnaire will be administered to parents. Items are answered "yes", "no", or "I don't know", and higher scores indicate more signs of obstructive sleep-disordered breathing. |
At enrollment, during the single study visit (Day 1)
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Sleep-related quality of life questionnaire
Délai: At enrollment, during the single study visit (Day 1)
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The Obstructive Sleep Apnea-18 (OSA-18) questionnaire will be administered to parents. Higher scores indicate a greater impact of sleep-disordered breathing on quality of life. |
At enrollment, during the single study visit (Day 1)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TMAC-C2
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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