NCT07129967 Oromyofunctional Training: an Innovative Rehabilitation Program for Pediatric Obstructive Sleep Apnea
| NCT ID | NCT07129967 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Obstructive Sleep Apnea (OSA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-08-08 |
| 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 90 participants in total. It began in 2024-08-08 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. However, adenotonsillectomy, the standard therapeutic approach for children with OSA, is often inadequate. Research shows that 20-40% of children still have residual OSA symptoms after surgery. Therefore, exploring other treatment options, specifically for those patients who currently have insufficient therapeutic options, 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 obstructive sleep apnea (OSA). 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 6-12 * 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 * Mental retardation (\>2 SD above P50)
Contact & Investigator
Kristiane Van Lierde, PhD
PRINCIPAL INVESTIGATOR
University Ghent
Frequently Asked Questions
Who can join the NCT07129967 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 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 NCT07129967 currently recruiting?
Yes, NCT07129967 is actively recruiting participants. Contact the research team at joliverb.verbeke@ugent.be for enrollment information.
Where is the NCT07129967 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT07129967 clinical trial?
NCT07129967 is sponsored by University Ghent. The principal investigator is Kristiane Van Lierde, PhD at University Ghent. The trial plans to enroll 90 participants.