Obstructive Sleep Apnea (OSA)OROFIT-PNCT07122505
Oromyofunctional Therapy: a Rehabilitation Program for OSA in Children With Down Syndrome and Prader-Willi Syndrome
A study testing Orofacial myofunctional therapy in people with Obstructive Sleep Apnea (OSA) and Orofacial Myofunctional Disorders, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Orofacial Myofunctional Disorders
- What is being tested?
- Orofacial myofunctional therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Apr 2024to 1 Jan 2027
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged between 4-18
- Diagnosed with Down syndrome or Prader-Willi syndrome
- Diagnosed with Obstructive Sleep Apnea on Polysomnography (AHI<1)
Who cannot join
- History of Orofacial Myofunctional Therapy
- Undergoing an orthodontic procedure during the study period
- Undegoing an OSA treatment during the study period
- Orofacial congenital deformities (not related to Down syndrome or Prader-Willi syndrome)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University
Ghent, 9000
Jolien Verbeke, +32 9 332 01 43, joliverb.verbeke@ugent.be
Kristiane Van Lierde, PhD
About this study
Official title: Oromyofunctional Training: an Innovative Rehabilitation Program for Pediatric Obstructive Sleep Apnea
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. Children with Down syndrome and Prader-Willi syndrome have many predisposing factors for OSA, including mouth breathing, narrow upper airways resulting from craniofacial abnormalities, and generalized hypotonia, which increases UA collapsibility and multilevel obstructions. Adenotonsillectomy is the first-line treatment. Unfortunately, up to 55% of children with Down syndrome and up to 79% of children with Prader-Willi syndrome suffer from residual OSA after adenotonsillectomy. Therefore, exploring other treatment options for these children 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 Down syndrome or Prader-Willi syndrome and obstructive sleep apnea. 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.
Read the detailed description
Objective: Determine the effect of 20 weeks of orofacial myofunctional therapy on oromyofunctional, sleep and sleep-related quality of life outcomes in children with OSA (AHI > 1) and Down syndrome or Prader-Willi syndrome.
- Being tested
- Orofacial myofunctional therapy
- Keywords
- Orofacial myofunctional therapy, Obstructive sleep apnea, Down syndrome, Prader-Willi syndrome
- Medical subject headings
- Sleep Apnea, Obstructive, Down Syndrome, Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orofacial myofunctional therapyBehavioural
Also called Oromyofunctional therapy, Oropharyngeal exercises
Orofacial myofunctional therapy consists of a set of oropharyngeal exercises to correct abnormal orofacial functions such as mouth breathing and a caudal tongue position, and strengthen upper airway muscles (e.g., muscles of the tongue and soft palate) that are involved in maintaining airway patency.
| Study group | Role | What they receive |
|---|---|---|
| OSA-patients | Experimental | orofacial myofunctional therapy Receives: Behavioral: Orofacial myofunctional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep: change in OAHI
Obstructive apnea hypopnea index measured by polysomnography
Measured: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Secondary outcomes (6)
Orofacial Myofunctional Outcomes: OMES score
core on the 'Orofacial Myofunctional Evaluation with scores' protocol.
Measured: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Orofacial strength
Lip and tongue strength measured with the Iowa Oral Performance Instrument.
Measured: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Quality of Life outcomes: CHQ-PF28
Child Health Questionnaire (CHQ-PF28)
Measured: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Sleep: PSQ
Score on the Pediatric Sleep Questionnaire
Measured: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Sleep: BSQ
Score on the Berlin Sleep Questionnaire
Measured: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Sleep: PSG
Polysomnography: - Oxygen Desaturation Index - Saturation 93% - Minimum saturation - Mean saturation - Sleep efficiency - Apnea Index (AI) (- Apnea-Hyponea Index (AHI) = primary outcome derived from PSG)
Measured: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start15 Apr 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristiane Van Lierde, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122505
- Sponsor's protocol ID
- ONZ-2024-0002
- Acronym
- OROFIT-P
- Status last verified
- Aug 2025
- First submitted
- 28 Apr 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oromyofunctional Training: an Innovative Rehabilitation Program for Pediatric Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07122505
- Acronym / sponsor ID
- OROFIT-P / ONZ-2024-0002
- Keywords
- Orofacial myofunctional therapy, Obstructive sleep apnea, Down syndrome, Prader-Willi syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Children with Down syndrome and Prader-Willi syndrome have many predisposing factors for OSA, including mouth breathing, narrow upper airways resulting from craniofacial abnormalities, and generalized hypotonia, which increases UA collapsibility and multilevel obstructions. Adenotonsillectomy is the first-line treatment. Unfortunately, up to 55% of children with Down syndrome and up to 79% of children with Prader-Willi syndrome suffer from residual OSA after adenotonsillectomy. Therefore, exploring other treatment options for these children 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 Down syndrome or Prader-Willi syndrome and obstructive sleep apnea. 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 20 weeks of orofacial myofunctional therapy on oromyofunctional, sleep and sleep-related quality of life outcomes in children with OSA (AHI > 1) and Down syndrome or Prader-Willi syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSA-patients | Experimental | Behavioral: Orofacial myofunctional therapyorofacial myofunctional therapy |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children aged between 4-18
- Diagnosed with Down syndrome or Prader-Willi syndrome
- Diagnosed with Obstructive Sleep Apnea on Polysomnography (AHI<1)
Key exclusion criteria (4 listed)
- History of Orofacial Myofunctional Therapy
- Undergoing an orthodontic procedure during the study period
- Undegoing an OSA treatment during the study period
- Orofacial congenital deformities (not related to Down syndrome or Prader-Willi syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orofacial myofunctional therapyAlso: Oromyofunctional therapy, Oropharyngeal exercisesOrofacial myofunctional therapy consists of a set of oropharyngeal exercises to correct abnormal orofacial functions such as mouth breathing and a caudal tongue position, and strengthen upper airway muscles (e.g., muscles of the tongue and soft palate) that are involved in maintaining airway patency. | Behavioural | OSA-patients |
Primary outcome
Sleep: change in OAHI
Time frame: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Obstructive apnea hypopnea index measured by polysomnography
6 secondary outcomes
Orofacial Myofunctional Outcomes: OMES score
Time frame: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Orofacial strength
Time frame: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Quality of Life outcomes: CHQ-PF28
Time frame: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Sleep: PSQ
Time frame: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Sleep: BSQ
Time frame: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Sleep: PSG
Time frame: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea (OSA)
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristiane Van Lierde, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orofacial myofunctional therapy in people with Obstructive Sleep Apnea (OSA) and Orofacial Myofunctional Disorders, run by University Ghent at 1 site in Belgium.
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 4 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 14 Aug 2025. 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 Belgium. 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 Jolien Verbeke, MSc (+32495195718, joliverb.verbeke@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep: change in OAHI (time frame: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.