Oromyofunctional Therapy: a Rehabilitation Program for OSA in Children With Down Syndrome and Prader-Willi Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Orofacial myofunctional therapy.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea (OSA), Orofacial Myofunctional Disorders. Basic parameters: 4 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Oromyofunctional Training: an Innovative Rehabilitation Program for Pediatric Obstructive Sleep Apnea
Overview
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
- Behavioral Orofacial 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.
Primary outcome measures
- Sleep: change in OAHI [Time frame: measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)]
Secondary outcome measures (6)
- 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)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Ghent University — Ghent
Identifiers
NCT: NCT07122505 · ONZ-2024-0002