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NCT Number: NCT07122505

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

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.

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Abnormalities, Multiple Apnea Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Dyssomnias Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Orofacial Myofunctional Disorders Overnutrition Overweight Prader-Willi Syndrome Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Jolien Verbeke

CONTACT

[email protected]

+32 9 332 01 43

Kristiane Van Lierde, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Oromyofunctional therapy, Oropharyngeal exercises

Primary outcomes

  1. Sleep: change in OAHI

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

    Obstructive apnea hypopnea index measured by polysomnography

Secondary outcomes

  1. Orofacial Myofunctional Outcomes: OMES score

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

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

  2. Orofacial strength

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

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

  3. Quality of Life outcomes: CHQ-PF28

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

    Child Health Questionnaire (CHQ-PF28)

  4. Sleep: PSQ

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

    Score on the Pediatric Sleep Questionnaire

  5. Sleep: BSQ

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

    Score on the Berlin Sleep Questionnaire

  6. Sleep: PSG

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

    Polysomnography: - Oxygen Desaturation Index - Saturation 93% - Minimum saturation - Mean saturation - Sleep efficiency - Apnea Index (AI) (- Apnea-Hyponea Index (AHI) = primary outcome derived from PSG)

Study contacts

Contact information is provided by the study sponsor or research team.

Jolien Verbeke, MSc

CONTACT

[email protected]

+32495195718

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

Oromyofunctional Training: an Innovative Rehabilitation Program for Pediatric Obstructive Sleep Apnea

Acronym: OROFIT-P

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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