An interventional study of Myofunctional therapy in Obstructive Sleep Apnea (OSA) and Obesity, sponsored by Université Catholique de Louvain. Not yet recruiting. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Treatment
Obstructive sleep-disordered breathing (oSDB) in children ranges from primary snoring to OSAHS and has cardiovascular and cognitive-behavioral consequences. In obese children, prevalence reaches 13-59%, and obesity and OSAHS reinforce each other through mechanical and metabolic pathways. Institutional weight-loss programs are first-line treatment but leave about 20% of children with persistent oSDB. Since tongue neuromuscular function supports upper-airway patency and myofunctional therapy reduces the pediatric apnea-hypopnea index by approximately 43%, this protocol tests whether adding myofunctional rehabilitation to a weight-loss program further improves outcomes in obese children with OSAHS, with follow-up at three months.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 62 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Université Catholique de Louvain is the lead sponsor of 154 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Supervised myofunctional therapy in addition to standard care (weight loss program)
Other: Myofunctional therapy
Standard care (weight loss program)
3 to 5 sessions of 20-30 min. each per week, for 3 months
Apnea-hypopnea index (AHI)
Sleep polygraphy
Time frame: Throughout the entire study, during approximately 4 years
Tongue strength assessment
Maximal pressure exerted by the tongue against an air-filled bulb (in kPa) in protrusion, elevation, and during swallowing.
Time frame: Throughout the entire study, during approximately 4 years
Tongue morphology assessment
Submental ultrasound in frontal and sagittal plane, to assess the thickness of tongue muscles (cm)
Time frame: Throughout the entire study, during approximately 4 years
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: Throughout the entire study, during approximately 4 years
Sleep quality questionnaire
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.
Time frame: Throughout the entire study, during approximately 4 years
Semi-structured interview
A semi-structured interview will be conducted to collect qualitative data on sleep quality
Time frame: Throughout the entire study, during approximately 4 years
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: Throughout the entire study, during approximately 4 years
Breathing pattern questionnaire
Mouth breathing questionnaire from Abreu et al., considered positive if two major items, or one major and two minor items, are answered "yes"
Time frame: Throughout the entire study, during approximately 4 years
Temporomandibular (TMD) pain screener
This questionnaire will be used to assess the presence of any temporomandibular joint disorder.
Time frame: Throughout the entire study, during approximately 4 years
3 questions/temporomandibular (3Q/TMD) questionnaire
This questionnaire will be used to assess the presence of any temporomandibular joint disorder.
Time frame: Throughout the entire study, during approximately 4 years
Adherence to rehabilitation protocol
Adherence will be monitored through a participation log of the rehabilitation sessions.
Time frame: Throughout the entire study, during approximately 4 years
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Sep 2030, 45 months later.
Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 45 months is above that.
Counting every sponsor, half of 623 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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