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

University Ghent

Status: Enrolling

Conditions: Obstructive Sleep Apnea (OSA); Orofacial Myofunctional Disorders

Treatments: Behavioral: Orofacial myofunctional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07129967

ONZ-2024-0003

Details and patient eligibility

About

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.

Full 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)

Enrollment: 90 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

OSA-patients

Experimental group

Description:

orofacial myofunctional therapy

Treatment:

Behavioral: Orofacial myofunctional therapy