Orofacial muscle training for children with obstructive sleep apnea
Oromyofunctional Training: an Innovative Rehabilitation Program for Pediatric Obstructive Sleep Apnea
This trial will test whether 12 weeks of orofacial muscle exercises help children aged 6–12 with obstructive sleep apnea (AHI > 1) sleep better and feel better during the day.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Trial ID | NCT07129967 on ClinicalTrials.gov |
What this trial studies
Children with polysomnography-confirmed obstructive sleep apnea will receive a 12-week program of orofacial myofunctional therapy consisting of structured oropharyngeal exercises to correct orofacial function and strengthen upper airway muscles. Outcomes will include objective sleep measures (including AHI from polysomnography), clinical oromyofunctional assessments, and sleep-related quality of life reported by caregivers or patients. Measures will be collected before and after the intervention to determine change over the treatment period. The program is delivered at Ghent University and excludes children already receiving other OSA treatments or orthodontic procedures.
Who should consider this trial
Good fit: Children aged 6–12 with polysomnography-confirmed obstructive sleep apnea (AHI > 1) who are not currently undergoing other OSA treatments or orthodontic procedures and who have not previously received orofacial myofunctional therapy.
Not a fit: Children with congenital orofacial deformities, significant intellectual disability, or those undergoing other OSA treatments or orthodontic procedures during the study are unlikely to be eligible or to receive benefit from this program.
Why it matters
Potential benefit: If successful, this non-surgical exercise program could reduce OSA severity and improve sleep and daytime quality of life for children, potentially lowering the need for additional procedures.
How similar studies have performed: Some prior clinical reports and small studies in adults and children suggest orofacial myofunctional therapy can improve airway function and sleep measures, but high-quality pediatric trial evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged between 6-12 * Diagnosed with Obstructive Sleep Apnea on Polysomnography (AHI\<1) Exclusion Criteria: * History of Orofacial Myofunctional Therapy * Undergoing an orthodontic procedure during the study period * Undegoing an OSA treatment during the study period * Orofacial congenital deformities * Mental retardation (\>2 SD above P50)
Where this trial is running
Ghent
- Ghent University — Ghent, Belgium (Recruiting)
Study contacts
- Principal investigator: Kristiane Van Lierde, PhD — University Ghent
- Study coordinator: Jolien Verbeke, MSc
- Email: joliverb.verbeke@ugent.be
- Phone: +32 9 332 01 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.