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

NCT ID: NCT07129967

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-08
• Study Completion Date: 2027-01-01

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.

Detailed Description

Objective: Determine the effect of 12 weeks of orofacial myofunctional therapy on oromyofunctional, sleep and sleep-related quality of life outcomes in children with OSA (AHI > 1)

Conditions

Obstructive Sleep Apnea (OSA); Orofacial Myofunctional Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OSA-patients

orofacial myofunctional therapy

Group Type: EXPERIMENTAL

Orofacial myofunctional therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Oromyofunctional therapy; Oropharyngeal exercises

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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristiane Van Lierde, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Ghent University

Ghent, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jolien Verbeke, MSc

Role: CONTACT

joliverb.verbeke@ugent.be

+32 9 332 01 43

Facility Contacts

Jolien Verbeke

Role: primary

joliverb.verbeke@ugent.be

+32 9 332 01 43

Other Identifiers

ONZ-2024-0003

Identifier Type: -

Identifier Source: org_study_id