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Oromyofunctional Therapy: a Rehabilitation Program for OSA in Children With Down Syndrome and Prader-Willi Syndrome

Key facts

Where
Ghent, BelgiumSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with Down syndrome or Prader-Willi syndrome who have obstructive sleep apnea. It tests mouth and throat muscle exercises.

Age
4 to 18 years
Sex
All sexes can join.
Disease stage
Obstructive sleep apnea diagnosed on a sleep study (polysomnography), listed as AHI<1.
Earlier treatment
Children cannot have had orofacial myofunctional therapy before.

Main reasons for not taking part

  • Had orofacial myofunctional therapy before
  • Having orthodontic treatment during the study
  • Having other sleep apnea treatment during the study
  • Facial birth defects not related to Down syndrome or Prader-Willi syndrome

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 4 and 18 years old?

Source: NCT07122505, who can take part

Where in Belgium

  • Ghent UniversityGhent, BelgiumContact: Jolien VerbekeTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
University Ghent
Trial code
NCT07122505
Record updated
14 August 2025
Original description
Obstructive sleep apnea (OSA) is a prevalent medical condition with important implications for overall health and quality of life in both children. Therefore, it is important to treat OSA early and effectively. Children with Down syndrome and Prader-Willi syndrome have many predisposing factors for OSA, including mouth breathing, narrow upper airways resulting from craniofacial abnormalities, and generalized hypotonia, which increases UA collapsibility and multilevel obstructions. Adenotonsillectomy is the first-line treatment. Unfortunately, up to 55% of children with Down syndrome and up to 79% of children with Prader-Willi syndrome suffer from residual OSA after adenotonsillectomy. Therefore, exploring other treatment options for these children is an interesting and relevant avenue for research.Read full original descriptionShow less

Oromyofunctional Training: an Innovative Rehabilitation Program for Pediatric Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is a prevalent medical condition with important implications for overall health and quality of life in both children. Therefore, it is important to treat OSA early and effectively. Children with Down syndrome and Prader-Willi syndrome have many predisposing factors for OSA, including mouth breathing, narrow upper airways resulting from craniofacial abnormalities, and generalized hypotonia, which increases UA collapsibility and multilevel obstructions. Adenotonsillectomy is the first-line treatment. Unfortunately, up to 55% of children with Down syndrome and up to 79% of children with Prader-Willi syndrome suffer from residual OSA after adenotonsillectomy. Therefore, exploring other treatment options for these children is an interesting and relevant avenue for research.

This study will evaluate the effectiveness of orofacial myofunctional therapy as a treatment option for children with Down syndrome or Prader-Willi syndrome and obstructive sleep apnea. Orofacial myofunctional therapy consists of a set of oropharyngeal exercises to correct abnormal orofacial functions and strengthen upper airway muscles that are involved in maintaining airway patency. Both objective and subjective/patient-reported outcomes are collected to obtain a comprehensive understanding of the potential of orofacial myofunctional therapy as a treatment for OSA.

Inclusion: Children aged between 4-18; Diagnosed with Down syndrome or Prader-Willi syndrome; Diagnosed with Obstructive Sleep Apnea on Polysomnography (AHI<1).

Exclusion: History of Orofacial Myofunctional Therapy; Orofacial congenital deformities (not related to Down syndrome or Prader-Willi syndrome); Undergoing an orthodontic procedure during the study period; Undegoing an OSA treatment during the study period.

ClinicalTrials.gov NCT07122505