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

NCT07129967 | Recruiting DMC

• 1 other identifier: ONZ-2024-0003
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea (OSA); Orofacial Myofunctional Disorders

Keywords

Orofacial myofunctional therapy; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• Sleep: change in OAHI

  Obstructive apnea hypopnea index measured by polysomnography

  measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)

Secondary Outcomes (6)

• Orofacial Myofunctional Outcomes: OMES score

  measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)

• Orofacial strength

  measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)

• Quality of Life outcomes: CHQ-PF28

  measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)

• Sleep: PSQ

  measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)

• Sleep: BSQ

  measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)

Study Arms (1)

OSA-patients

EXPERIMENTAL

orofacial myofunctional therapy

Behavioral: Orofacial myofunctional therapy

Interventions

Orofacial myofunctional therapy 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.

Also known as: Oromyofunctional therapy, Oropharyngeal exercises

OSA-patients

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 6-12
• Diagnosed with Obstructive Sleep Apnea on Polysomnography (AHI\<1)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Myofunctional Therapy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Dentistry

Study Officials

• Kristiane Van Lierde, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jolien Verbeke, MSc

CONTACT

+32 9 332 01 43; joliverb.verbeke@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: August 19, 2025
• Study Start: August 8, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)