About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged between 4-18
Diagnosed with Down syndrome or Prader-Willi syndrome
Diagnosed with Obstructive Sleep Apnea on Polysomnography (AHI<1)
Disqualifiers
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 design
Single group
Treatments tested in this trial
Orofacial myofunctional therapy
BehavioralOrofacial 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.
Treatment groups
Trial outcomes
Primary outcomes
Sleep: change in OAHI
Obstructive apnea hypopnea index measured by polysomnography
Secondary outcomes
Orofacial Myofunctional Outcomes: OMES score
core on the 'Orofacial Myofunctional Evaluation with scores' protocol.
Orofacial strength
Lip and tongue strength measured with the Iowa Oral Performance Instrument.
Quality of Life outcomes: CHQ-PF28
Child Health Questionnaire (CHQ-PF28)
Sleep: PSQ
Score on the Pediatric Sleep Questionnaire
Sponsors and contacts
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