NCT07122505 Oromyofunctional Therapy: a Rehabilitation Program for OSA in Children With Down Syndrome and Prader-Willi Syndrome
| NCT ID | NCT07122505 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Obstructive Sleep Apnea (OSA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-04-15 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Kristiane Van Lierde, PhD
PRINCIPAL INVESTIGATOR
University Ghent
Frequently Asked Questions
Who can join the NCT07122505 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 18 Years, studying Obstructive Sleep Apnea (OSA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07122505 currently recruiting?
Yes, NCT07122505 is actively recruiting participants. Contact the research team at joliverb.verbeke@ugent.be for enrollment information.
Where is the NCT07122505 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT07122505 clinical trial?
NCT07122505 is sponsored by University Ghent. The principal investigator is Kristiane Van Lierde, PhD at University Ghent. The trial plans to enroll 60 participants.