Prince of Wales Hospital, The Chinese University of Hong Kong
Shatin, Hong Kong
NCT Number: NCT07249944
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.
Trial opening soon.
Get Notified6 year–12 year
All sexes
Interventional
Not applicable
Shatin, Hong Kong
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24 weeks
oAHI measured by PSG
Time frame: 24 weeks
Presence of oral breathing
Time frame: 24 weeks
Pediatric Sleep Questionnaire
Time frame: 24 weeks
Modified Epworth Sleepiness Scale
Time frame: 24 weeks
OSA-18 questionnaire
Time frame: 24 weeks
Child Behaviour Checklist
Time frame: 24 weeks
Lip and tongue strength and endurance measured using the Iowa Oral Performance Instrument
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
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
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.
Contact information is provided by the study sponsor or research team.
Chinese University of Hong Kong
Other
Myofunctional Therapy for Children With Obstructive Sleep Apnoea - a Multi-centre Randomised Controlled Trial
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.
NCT07730879
Apnea, Cardiovascular Diseases
Braga, Portugal
View Trial DetailsNCT07720219
Apnea, Dyssomnias
View Trial DetailsNCT07711678
Apnea, Dyssomnias
Beijing, Beijing Municipality, China
View Trial DetailsNCT07693101
Apnea, Dyssomnias
View Trial Details