Myofunctional Therapy for Children With OSA

Myofunctional Therapy for Children With Obstructive Sleep Apnoea - a Multi-centre Randomised Controlled Trial

Myofunctional therapy (MFT) has been proposed as an adjunctive therapy for obstructive sleep apnoea (OSA) in children.

Some studies have reported improved sleep parameters and reduced oral breathing after MFT. However, the level of evidence in these studies is limited, with most being case series or case-control studies. There have been only a few randomised controlled trials (RCTs), and these studies have had limitations such as low response rate, short follow-up periods, and the existing evidence does not adequately address the potential clinical benefits and the impact on craniofacial structure. Additionally, there is a lack of evidence regarding the effectiveness of additional measures, such as remote guidance and supervision, in improving treatment outcomes in children. Therefore, there is a need for further research to address these gaps and provide more robust evidence on the efficacy of MFT in children with OSA. The objective of this study is to investigate the efficacy of MFT in children with OSA through a multi-centre randomised controlled trial (RCT). 174 children aged 6-12 years old with OSA will be recruited and randomly assigned to either the intervention or control group. All children will undergo standardised evaluation at baseline and follow-up visits. In the intervention arm, a 24-week myofunctional therapy targeting orofacial MFT, breathing, and postural re-education, with incorporation of telemedicine for remote training and monitoring. In the control arm, children will receive standard care without MFT. The primary outcome measure will be obstructive apnoea hypopnoea index measured by polysomnography. Secondary outcome measures will be the oral breathing pattern, OSA-related symptoms, and quality of life. The treatment effect on outcomes will be examined using a mixed-effects model with an intention-to-treat approach. Subgroup analyses will explore potential effect modification by important participant characteristics, such as OSA severity and compliance. This study will generate evidence-based information regarding the efficacy of MFT in children with OSA and will inform clinical practice.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Behavioral: Myofunctional therapy

Detailed Description

Myofunctional therapy (MFT) has been proposed as an adjunctive therapy for obstructive sleep apnoea (OSA) in children. Some studies have reported improved sleep parameters and reduced oral breathing after MFT. However, the level of evidence in these studies is limited, with most being case series or case-control studies. There have been only a few randomised controlled trials (RCTs), and these studies have had limitations such as low response rate, short follow-up periods, and absence of polysomnographic measurement after intervention. Moreover, the existing evidence does not adequately address the potential clinical benefits and the impact on craniofacial structure. Additionally, there is a lack of evidence regarding the effectiveness of additional measures, such as remote guidance and supervision, in improving treatment outcomes in children. Therefore, there is a need for further research to address these gaps and provide more robust evidence on the efficacy of MFT in children with OSA.

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ching Ching, Kate CHAN, MD; Phone Number: (852) 3505 3515; Email: katechan@cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Prince of Wales Hospital, The Chinese University of Hong Kong
    • Principal Investigator: Kate Ching Ching Chan, MD
    • Contact: Joyce Choi; Phone Number: +852 35052917; Email: joycechoi@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children aged 6-12 years, with this age range, children start to have a greater ability to understand and follow instructions, making them more likely to comply and cooperate with the treatment procedures, and at the same time this age range remains a critical and modifiable developmental window when interventions can address underlying orofacial muscle and respiratory muscle dysfunctions and enhance the potential for long-term benefits.
2. Diagnosed with OSA based on clinical evaluation and polysomnography (oAHI ≥ 1/hour). The clinical evaluation will involve assessing the presence of habitual snoring, which is defined as snoring occurring 3 nights or more per week on average as reported by parents or caregivers, and any of the following features suggestive of SDB such as oral breathing, respiratory pauses, observed apnoeas, or increased work of breathing during sleep. Children with persistent OSA, documented by repeat PSG, can be included after receiving standard treatments (such as adenotonsillectomy treatment).
3. Informed consent from a parent or a legal guardian.

Exclusion Criteria:

• Genetic, syndromal, or metabolic disease
• Congenital or acquired neuromuscular disease
• Syndromal craniofacial abnormalities or previous craniofacial surgery
• Severe developmental delay (developmental or functional age <66% of chronological age)
• Children with OSA who are indicated for and will receive other treatments such as adenotonsillectomy, positive airway pressure therapy or orthodontic treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants in the intervention group will undergo a MFT programme with telemedicine support.	Behavioral: Myofunctional therapy; Myofunctional therapy (MFT) has been proposed as an adjunctive therapy for obstructive sleep apnoea (OSA) in children. Some studies have reported improved sleep parameters and reduced oral breathing after MFT.
No Intervention: Controls; Participants in the control group will receive standard care, such as anti-inflammatory medications if indicated, without the Myofunctional therapy .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oAHI measured by PSG	oAHI measured by PSG	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of oral breathing	Presence of oral breathing	24 weeks
Symptoms of sleep-disordered breathing	Pediatric Sleep Questionnaire	24 weeks
Daytime sleepiness	Modified Epworth Sleepiness Scale	24 weeks
OSA specific quality of life	OSA-18 questionnaire	24 weeks
Child behavioural and emotional measures	Child Behaviour Checklist	24 weeks
Lip and tongue strength and endurance	Lip and tongue strength and endurance measured using the Iowa Oral Performance Instrument	24 weeks
Free tongue length	Free tongue length measured using the Quick Tongue-tie Assessment Tool from the insertion of the lingual frenulum to the tongue tip	24 weeks
Tongue mobility	Tongue mobility measured by Mpal/Mmax, where Mpal and Mmax refer to the maximal distance between incisors when the tongue tip touches the palatal papilla and during whole mouth opening, respectively	24 weeks
Photogrammetry	Craniofacial landmarks will be located and recorded as pixel coordinates on the image following established procedures. Measurements of craniofacial linear distances, angles, and upper body posture will be calculated.	24 weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: The University of Hong Kong; Prince of Wales Hospital, Shatin, Hong Kong; Queen Mary Hospital, Hong Kong; Kwong Wah Hospital; United Christian Hospital
• Investigators: Principal Investigator: Ching Ching, Kate CHAN, MD, Department of Paediatrics, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Children; Randomised controlled trial; Intervention; Obstructive sleep apnoea; Myofunctional therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Rehabilitation of Speech and Language Disorders; Dentistry; Myofunctional Therapy
• Other Study ID Numbers: MFTOSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No