ClinicalTrials.gov record NCT07122505

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age4 years old to 18 years old
SexAll
LocationBelgium
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This single-group study gives orofacial myofunctional therapy (a program of oropharyngeal exercises) to children with OSA who also have Down syndrome or Prader‑Willi syndrome. Therapy is delivered over 20 weeks and outcomes are measured before and after treatment. Measures include an overnight sleep study and questionnaires about sleep and quality of life.

What it is studying. Whether 20 weeks of orofacial myofunctional therapy affects sleep-disordered breathing, orofacial function, muscle strength, and sleep-related quality of life in children with obstructive sleep apnea and Down syndrome or Prader‑Willi syndrome.

What the researchers hope to learn. To measure changes in obstructive apnea-hypopnea index (OAHI) on polysomnography, orofacial myofunctional scores (OMES), lip and tongue strength, and sleep-related quality-of-life and questionnaire scores after the therapy.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Behavioral
  • Orofacial myofunctional therapy

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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)

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Objective: Determine the effect of 20 weeks of orofacial myofunctional therapy on oromyofunctional, sleep and sleep-related quality of life outcomes in children with OSA (AHI > 1) and Down syndrome or Prader-Willi syndrome.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Take part in a 20-week program of orofacial myofunctional therapy (mouth and throat exercises). Tests and assessments are done before and after the 20 weeks and include an overnight sleep study (polysomnography), orofacial function evaluation (OMES), lip and tongue strength measurement with the Iowa Oral Performance Instrument, and questionnaires about sleep and quality of life. Participants must not receive other OSA treatments or start orthodontic procedures during the study, and prior orofacial myofunctional therapy excludes participation.

How the study is structured. Interventional treatment study where all participants receive the same behavioral therapy (no placebo or comparison group). The study is not masked. Participants are assessed before starting therapy and again after 20 weeks of therapy using sleep studies and clinical/functional measures.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Obstructive Sleep Apnea (OSA); Orofacial Myofunctional Disorders. Does it apply to my diagnosis?
  • The listed sites are in Belgium. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Prader-Willi syndrome

Clinical trials19 trials listed for Prader-Willi syndromeEvery trial the registry lists for Prader-Willi syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Prader-Willi syndrome researchLatest monthly update: September 2026. Includes: Hunger symptoms. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Apr 15, 2024
Primary completion
Oct 1, 2026 (estimated)
Study completion
Jan 1, 2027 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
Aug 14, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University Ghent

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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