Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07249944

Myofunctional Therapy for Children With OSA

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, Hong Kong

Location contact

Joyce Choi

CONTACT

[email protected]

+852 35052917

Kate Ching Ching Chan, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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).
  • 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.

Treatment and study plan

Myofunctional therapy

Behavioral

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.

Primary outcomes

  1. oAHI measured by PSG

    Time frame: 24 weeks

    oAHI measured by PSG

Secondary outcomes

  1. Presence of oral breathing

    Time frame: 24 weeks

    Presence of oral breathing

  2. Symptoms of sleep-disordered breathing

    Time frame: 24 weeks

    Pediatric Sleep Questionnaire

  3. Daytime sleepiness

    Time frame: 24 weeks

    Modified Epworth Sleepiness Scale

  4. OSA specific quality of life

    Time frame: 24 weeks

    OSA-18 questionnaire

  5. Child behavioural and emotional measures

    Time frame: 24 weeks

    Child Behaviour Checklist

  6. Lip and tongue strength and endurance

    Time frame: 24 weeks

    Lip and tongue strength and endurance measured using the Iowa Oral Performance Instrument

  7. Free tongue length

    Time frame: 24 weeks

    Free tongue length measured using the Quick Tongue-tie Assessment Tool from the insertion of the lingual frenulum to the tongue tip

  8. Tongue mobility

    Time frame: 24 weeks

    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

  9. Photogrammetry

    Time frame: 24 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ching Ching, Kate CHAN, MD

CONTACT

[email protected]

(852) 3505 3515

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Kwong Wah Hospital
  • Prince of Wales Hospital, Shatin, Hong Kong
  • Queen Mary Hospital, Hong Kong
  • The University of Hong Kong
  • United Christian Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.