Actively Recruiting

Phase Not Applicable
Age: 4Years - 18Years
All Genders
ID07122505

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

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

60

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Obstructive sleep apnea (OSA) is a common condition affecting children's health and quality of life, especially those with Down syndrome or Prader-Willi syndrome. These children often have factors like mouth breathing, narrow airways, and muscle weakness that increase their risk of OSA. Standard treatment is adenotonsillectomy, but many still have OSA after surgery, so new treatments are needed. This research evaluates orofacial myofunctional therapy as a possible treatment to improve airway function in these children. Orofacial myofunctional therapy involves exercises to correct abnormal mouth and throat functions and strengthen muscles that keep the airway open. This study provides 20 weeks of this therapy to children with OSA and Down syndrome or Prader-Willi syndrome. The therapy aims to improve breathing and sleep by targeting muscle function. The study collects both objective measurements and patient-reported outcomes before and after the therapy period. Participants will undergo assessments before starting therapy and after completing 20 weeks of exercises. These include sleep studies measuring airway obstruction, scores evaluating mouth and throat function, muscle strength tests, and quality of life questionnaires. Researchers will track changes in OSA severity and related symptoms to understand the therapy's impact. The study is led by University Ghent and involves children aged 4 to 18 years with specific diagnoses.

CONDITIONS

Brief 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 on polysomnography (AHI > 1)
Not Eligible

You will not qualify if you...

  • History of orofacial myofunctional therapy
  • Undergoing an orthodontic procedure during the study period
  • Undergoing an obstructive sleep apnea treatment during the study period
  • 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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 20 weeks

Participants undergo 20 weeks of orofacial myofunctional therapy, which involves exercises to improve orofacial functions and strengthen airway muscles.

Weekly visits for therapy sessions

Trial Site Locations

Total: 1 location

1

Ghent University

Ghent, Belgium, 9000

Actively Recruiting

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Research Team

J

Jolien Verbeke, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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