Actively Recruiting

Phase Not Applicable
Age: 4Years - 18Years
All Genders
NCT07122505

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

Led by University Ghent · Updated on 2025-08-14

60

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 4Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged between 4 and 18 years
  • Diagnosed with Down syndrome or Prader-Willi syndrome
  • Diagnosed with obstructive sleep apnea confirmed by polysomnography (AHI > 1)
Not Eligible

You will not qualify if you...

  • History of orofacial myofunctional therapy
  • Currently undergoing orthodontic treatment during the study period
  • Receiving any obstructive sleep apnea treatment during the study period
  • Presence of orofacial congenital deformities not related to Down syndrome or Prader-Willi syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Ghent University

Ghent, Belgium, 9000

Actively Recruiting

Loading map...

Research Team

J

Jolien Verbeke, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here