Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-17
SponsorUniversité Catholique de Louvain
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 4 to 17 years
Scheduled polysomnography, or polysomnography performed within the past 6 months
Positive Pediatric Sleep Questionnaire (8 "yes" answers or more)
Disqualifiers
Any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III
Any condition that could interfere with the assessments
Trial population
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
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Cross-sectional assessment
Other interventionThis cross-sectional assessment includes outcomes related to tongue structure, tongue function, and questionnaires
Treatment groups
39 Participants
are divided into 1 treatment groupGroup A: Unique arm, cross-sectional assessment1 intervention
Trial outcomes
Primary outcomes
1
Tongue strength assessment
Maximal pressure exerted by the tongue against an air-filled bulb (in kPa) in protrusion, elevation, and during swallowing.
Time frame
At enrollment, during the single study visit (Day 1)Secondary outcomes
1
Tongue morphology assessment
Submental ultrasound in frontal and sagittal plane, to assess the thickness of tongue muscles (cm)
Time frame
At enrollment, during the single study visit (Day 1)2
Tongue frenulum assessment
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).
Time frame
At enrollment, during the single study visit (Day 1)3
Tongue mobility score
Motricité Bucco-Linguo-Faciale (MBLF) test, where several movements are scored between 0 and 3 regarding muscular contraction or symmetry.
Time frame
At enrollment, during the single study visit (Day 1)4
Obstructive apnea-hypopnea index
Number of obstructive apneas and hypopneas per hour of sleep (events/hour) assessed through polysomnography
Time frame
At enrollment, during the single study visit (Day 1)Sponsors and contacts
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Université Catholique de Louvain
Lead sponsor
CHC MontLégia
Collaborator
Source ClinicalTrials.gov