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Recruiting Not applicable

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

NCT07122505 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2024-04-15
Last updated
2025-08-14

Condition(s) studied

Obstructive Sleep Apnea (OSA)Orofacial Myofunctional Disorders

Investigational drug(s) / intervention(s)

Orofacial myofunctional therapy

Orofacial myofunctional therapy: Orofacial myofunctional therapy consists of a set of oropharyngeal exercises to correct abnormal orofacial functions such as mouth breathing and a caudal tongue position, and strengthen upper airway muscles (e.g., muscles of the tongue and soft palate) that are involved in maintaining airway patency.

Study summary

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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
18 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Sleep: change in OAHI — measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
    Obstructive apnea hypopnea index measured by polysomnography

Trial sites (1)

FacilityCityRegionStatus
Ghent University Ghent Belgium Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07122505 on ClinicalTrials.gov ↗ ← All trials in Belgium