Orofacial muscle therapy for children with Down syndrome or Prader–Willi syndrome and obstructive sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.