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

NCT07122505 | Recruiting DMC

• 1 other identifier: ONZ-2024-0002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea (OSA); Orofacial Myofunctional Disorders

Keywords

Orofacial myofunctional therapy; Obstructive sleep apnea; Down syndrome; Prader-Willi syndrome

Outcome Measures

Primary Outcomes (1)

• Sleep: change in OAHI

  Obstructive apnea hypopnea index measured by polysomnography

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

Secondary Outcomes (6)

• Orofacial Myofunctional Outcomes: OMES score

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

• Orofacial strength

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

• Quality of Life outcomes: CHQ-PF28

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

• Sleep: PSQ

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

• Sleep: BSQ

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

Study Arms (1)

OSA-patients

EXPERIMENTAL

orofacial myofunctional therapy

Behavioral: Orofacial myofunctional therapy

Interventions

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.

Also known as: Oromyofunctional therapy, Oropharyngeal exercises

OSA-patients

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged between 4-18
• Diagnosed with Down syndrome or Prader-Willi syndrome
• Diagnosed with Obstructive Sleep Apnea on Polysomnography (AHI\<1)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Down Syndrome; Prader-Willi Syndrome

Interventions

Myofunctional Therapy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Dentistry

Study Officials

• Kristiane Van Lierde, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jolien Verbeke, MSc

CONTACT

+32495195718; joliverb.verbeke@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: August 14, 2025
• Study Start: April 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)