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

Not Applicable

Recruiting

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

• Registration Number: NCT07129967
• Lead Sponsor: University Ghent

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)

Study Timeline

• Study Start: 2024-08-08
• Study First Submitted: 2025-04-28
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Primary Completion: 2026-10-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sleep: change in OAHI	measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)	Obstructive apnea hypopnea index measured by polysomnography

Secondary Outcome Measures

Name	Time	Method
Orofacial Myofunctional Outcomes: OMES score	measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)	Score on the 'Orofacial Myofunctional Evaluation with scores' protocol.
Orofacial strength	measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)	Lip and tongue strength measured with the Iowa Oral Performance Instrument.
Sleep: PSQ	measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)	Score on the Pediatric Sleep Questionnaire
Sleep: BSQ	measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)	Score on the Berlin Sleep Questionnaire
Quality of Life outcomes: CHQ-PF28	measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)	Child Health Questionnaire (CHQ-PF28)
Sleep: PSG	measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)	Polysomnography: * Oxygen Desaturation Index; * Saturation 93%; * Minimum saturation; * Mean saturation; * Sleep efficiency; * Apnea Index (AI); (- Apnea-Hyponea Index (AHI) = primary outcome derived from PSG)

Trial Locations

Locations (1)

Ghent University; 🇧🇪 Ghent, Belgium