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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. However, adenotonsillectomy, the standard therapeutic approach for children with OSA, is often inadequate. Research shows that 20-40% of children still have residual OSA symptoms after surgery. Therefore, exploring other treatment options, specifically for those patients who currently have insufficient therapeutic options, 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 obstructive sleep apnea (OSA). 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.
Objective: Determine the effect of 12 weeks of orofacial myofunctional therapy on oromyofunctional, sleep and sleep-related quality of life outcomes in children with OSA (AHI > 1)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA-patients | Experimental | orofacial myofunctional therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orofacial myofunctional therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep: change in OAHI | Obstructive apnea hypopnea index measured by polysomnography | measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Orofacial Myofunctional Outcomes: OMES score | Score on the 'Orofacial Myofunctional Evaluation with scores' protocol. | measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy) |
| Orofacial strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jolien Verbeke, MSc | Contact | +32 9 332 01 43 | joliverb.verbeke@ugent.be |
| Name | Affiliation | Role |
|---|---|---|
| Kristiane Van Lierde, PhD | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University | Recruiting | Ghent | 9000 | Belgium |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D020247 | Myofunctional Therapy |
| ID | Term |
|---|---|
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
Lip and tongue strength measured with the Iowa Oral Performance Instrument.
| measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy) |
| Quality of Life outcomes: CHQ-PF28 | Child Health Questionnaire (CHQ-PF28) | measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy) |
| Sleep: PSQ | Score on the Pediatric Sleep Questionnaire | measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy) |
| Sleep: BSQ | Score on the Berlin Sleep Questionnaire | measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy) |
| Sleep: PSG | Polysomnography:
(- Apnea-Hyponea Index (AHI) = primary outcome derived from PSG) | measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy) |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D003813 | Dentistry |