Obstructive Sleep Apnea (OSA), Orofacial Myofunctional Disorders
Conditions
Keywords
Orofacial myofunctional therapy, Obstructive sleep apnea, Down syndrome, Prader-Willi syndrome
Brief 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. 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.
Interventions
BEHAVIORALOrofacial myofunctional therapy
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.
Sponsors
University Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children aged between 4-18 * Diagnosed with Down syndrome or Prader-Willi syndrome * Diagnosed with Obstructive Sleep Apnea on Polysomnography (AHI\<1)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep: change in OAHI | measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy) | Obstructive apnea hypopnea index measured by polysomnography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Orofacial strength | measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy) | Lip and tongue strength measured with the Iowa Oral Performance Instrument. |
| Quality of Life outcomes: CHQ-PF28 | measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy) | Child Health Questionnaire (CHQ-PF28) |
| Orofacial Myofunctional Outcomes: OMES score | measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy) | core on the 'Orofacial Myofunctional Evaluation with scores' protocol. |
| Sleep: BSQ | measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy) | Score on the Berlin Sleep Questionnaire |
| Sleep: PSG | measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy) | Polysomnography: - Oxygen Desaturation Index - Saturation 93% - Minimum saturation - Mean saturation - Sleep efficiency - Apnea Index (AI) (- Apnea-Hyponea Index (AHI) = primary outcome derived from PSG) |
| Sleep: PSQ | measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy) | Score on the Pediatric Sleep Questionnaire |
Countries
Belgium
Contacts
Primary ContactJolien Verbeke, MSc
Outcome results
None listed