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).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: William Poncin, Professor
- Telefonnummer: 0471 90 66 23
- E-post: william.poncin@uclouvain.be
Studiesteder
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Liège, Belgia, 4000
- Rekruttering
- CHC MontLégia hospital
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Ta kontakt med:
- Matthieu Thimmesch, MD
- Telefonnummer: 0032 4 355 50 20
- E-post: Matthieu.THIMMESCH@chc.be
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CONTROL
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Tongue strength assessment
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Tongue morphology assessment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TMAC-C2
Plan for individuelle deltakerdata (IPD)
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