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Obstructive Sleep Apnea (OSA)NCT07249944

Myofunctional Therapy for Children With OSA

A study testing Myofunctional therapy in people with Obstructive Sleep Apnea (OSA), run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Obstructive Sleep Apnea (OSA)
What is being tested?
Myofunctional therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteHong Kong
Study dates
1 Dec 2025to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ching Ching, Kate CHAN, MD contact

(852) 3505 3515

katechan@cuhk.edu.hk

Hong Kong1 site, 1 recruiting

  • Prince of Wales Hospital, The Chinese University of Hong Kong

    Shatin

    Joyce Choi, +852 35052917, joycechoi@cuhk.edu.hk

    Kate Ching Ching Chan, MD

    Recruiting

Other trials in Hong Kong

About this study

Official title: 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.

Read the 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.

Being tested
Myofunctional therapy
Keywords
Children, Obstructive sleep apnoea, Myofunctional therapy, Randomised controlled trial, Intervention
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Myofunctional therapyBehavioural

    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.

Study groups in NCT07249944
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants in the intervention group will undergo a MFT programme with telemedicine support.
Receives: Behavioral: Myofunctional therapy
ControlsNo interventionParticipants in the control group will receive standard care, such as anti-inflammatory medications if indicated, without the Myofunctional therapy .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. oAHI measured by PSG

    oAHI measured by PSG

    Measured: 24 weeks

Secondary outcomes (9)

  1. Presence of oral breathing

    Presence of oral breathing

    Measured: 24 weeks

  2. Symptoms of sleep-disordered breathing

    Pediatric Sleep Questionnaire

    Measured: 24 weeks

  3. Daytime sleepiness

    Modified Epworth Sleepiness Scale

    Measured: 24 weeks

  4. OSA specific quality of life

    OSA-18 questionnaire

    Measured: 24 weeks

  5. Child behavioural and emotional measures

    Child Behaviour Checklist

    Measured: 24 weeks

  6. Lip and tongue strength and endurance

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

    Measured: 24 weeks

  7. 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

    Measured: 24 weeks

  8. 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

    Measured: 24 weeks

  9. 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.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2025
  2. Study start1 Dec 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
174 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07249944
Sponsor's protocol ID
MFTOSA
Status last verified
Oct 2026
First submitted
1 Oct 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Myofunctional therapy in people with Obstructive Sleep Apnea (OSA), run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ching Ching, Kate CHAN, MD ((852) 3505 3515, katechan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

oAHI measured by PSG (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07249944.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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