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

University Ghent

Status

Enrolling

Conditions

Obstructive Sleep Apnea (OSA)

Orofacial Myofunctional Disorders

Treatments

Behavioral: Orofacial myofunctional therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07122505

ONZ-2024-0002

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

4 to 18 years old

Volunteers

No Healthy Volunteers

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)