Orofacial muscle therapy for children with Down syndrome or Prader–Willi syndrome and obstructive sleep apnea
Oromyofunctional Training: an Innovative Rehabilitation Program for Pediatric Obstructive Sleep Apnea
We will test whether 20 weeks of orofacial myofunctional therapy can reduce obstructive sleep apnea and improve sleep-related quality of life in children with Down syndrome or Prader–Willi syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Trial ID | NCT07122505 on ClinicalTrials.gov |
What this trial studies
Children aged 4–18 with Down syndrome or Prader–Willi syndrome and obstructive sleep apnea (AHI > 1) will receive a 20-week program of orofacial myofunctional therapy. Outcomes will be measured before and after the intervention using polysomnography, standardized oromyofunctional assessments, and sleep-related quality of life questionnaires. Participants with prior orofacial therapy, concurrent OSA treatment, ongoing orthodontic procedures, or unrelated congenital orofacial deformities are excluded. The intervention is delivered at Ghent University with in-person therapy sessions and scheduled outcome testing.
Who should consider this trial
Good fit: Children aged 4–18 who have Down syndrome or Prader–Willi syndrome and documented obstructive sleep apnea (AHI > 1) who are not currently receiving OSA treatment and have not had prior orofacial myofunctional therapy.
Not a fit: Children with severe anatomical airway obstruction requiring surgery, those already receiving OSA treatment, or those with unrelated congenital orofacial deformities are unlikely to benefit from this therapy.
Why it matters
Potential benefit: If successful, this non-surgical therapy could reduce OSA severity and improve sleep and daytime functioning for children with Down syndrome or Prader–Willi syndrome.
How similar studies have performed: Some studies in adults and in typically developing children show modest benefit from orofacial myofunctional therapy, but evidence in Down syndrome and Prader–Willi populations is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged between 4-18 * Diagnosed with Down syndrome or Prader-Willi syndrome * 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 (not related to Down syndrome or Prader-Willi syndrome)
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: +32495195718
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.