Oromyofunctional Therapy: a Rehabilitation Program for OSA in Children With Down Syndrome and Prader-Willi Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorUniversity Ghent

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: OSA-patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sleep: change in OAHI

Obstructive apnea hypopnea index measured by polysomnography

Time frame
measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)

Secondary outcomes

1

Orofacial Myofunctional Outcomes: OMES score

core on the 'Orofacial Myofunctional Evaluation with scores' protocol.

Time frame
measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
2

Orofacial strength

Lip and tongue strength measured with the Iowa Oral Performance Instrument.

Time frame
measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
3

Quality of Life outcomes: CHQ-PF28

Child Health Questionnaire (CHQ-PF28)

Time frame
measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)
4

Sleep: PSQ

Score on the Pediatric Sleep Questionnaire

Time frame
measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)

Other outcomes

Sponsors and contacts

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