Obstructive Sleep Apnea (OSA) and ObesityNCT07925294
The Impact of Myofunctional Therapy on Children With Sleep Apnea and Obesity
A study testing Myofunctional therapy in people with Obstructive Sleep Apnea (OSA) and Obesity, run by Université Catholique de Louvain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA) and Obesity
- What is being tested?
- Myofunctional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being aged from 10 to 17 years
- Having a BMI above 97th percentile according to age/sex, or above 35 for 17 year old children
Who cannot join
- Any reason preventing participation to the intervention protocol or the assessments (e.g., oral pain, severe cognitive impairment, non-cooperation, unable to read)
- Being already involved in an oropharyngeal rehabilitation protocol
- Any neuromuscular syndrome or cranio-facial malformation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Myofunctional therapy
- Keywords
- sleep apnea, obesity, children
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofunctional therapyOther
3 to 5 sessions of 20-30 min. each per week, for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Supervised myofunctional therapy in addition to standard care (weight loss program) Receives: Other: Myofunctional therapy |
| Control | No intervention | Standard care (weight loss program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index (AHI)
Sleep polygraphy
Measured: Throughout the entire study, during approximately 4 years
Secondary outcomes (4)
Tongue strength assessment
Maximal pressure exerted by the tongue against an air-filled bulb (in kPa) in protrusion, elevation, and during swallowing.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Throughout the entire study, during approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA) and ObesityStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, with age stratification (10-13 and 14-17 years).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Médical Pédiatrique Clairs Vallons
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07925294
- Sponsor's protocol ID
- MYOSA
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Myofunctional Therapy on Children With Sleep Apnea and Obesity
- ClinicalTrials.gov ID
- NCT07925294
- Acronym / sponsor ID
- MYOSA
- Keywords
- sleep apnea, obesity, children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Centre Médical Pédiatrique Clairs Vallons
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial, with age stratification (10-13 and 14-17 years).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Myofunctional therapySupervised myofunctional therapy in addition to standard care (weight loss program) |
| Control | No intervention | –Standard care (weight loss program) |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Being aged from 10 to 17 years
- Having a BMI above 97th percentile according to age/sex, or above 35 for 17 year old children
Key exclusion criteria (3 listed)
- Any reason preventing participation to the intervention protocol or the assessments (e.g., oral pain, severe cognitive impairment, non-cooperation, unable to read)
- Being already involved in an oropharyngeal rehabilitation protocol
- Any neuromuscular syndrome or cranio-facial malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofunctional therapy3 to 5 sessions of 20-30 min. each per week, for 3 months | Other | Intervention |
Primary outcome
Apnea-hypopnea index (AHI)
Time frame: Throughout the entire study, during approximately 4 years
Sleep polygraphy
4 secondary outcomes
Tongue strength assessment
Time frame: Throughout the entire study, during approximately 4 years
Tongue morphology assessment
Time frame: Throughout the entire study, during approximately 4 years
Tongue mobility score
Time frame: Throughout the entire study, during approximately 4 years
Sleep quality questionnaire
Time frame: Throughout the entire study, during approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Myofunctional therapy in people with Obstructive Sleep Apnea (OSA) and Obesity, run by Université Catholique de Louvain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Poncin, Professor (0471 90 66 23, william.poncin@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index (AHI) (time frame: Throughout the entire study, during approximately 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.