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

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea (OSA); Orofacial Myofunctional Disorders

• Registration Number: NCT07122505
• Lead Sponsor: University Ghent

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.

Detailed 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.

Study Timeline

• Study Start: 2024-04-15
• Study First Submitted: 2025-04-28
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2026-10-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sleep: change in OAHI	measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)	Obstructive apnea hypopnea index measured by polysomnography

Secondary Outcome Measures

Name	Time	Method
Orofacial Myofunctional Outcomes: OMES score	measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)	core on the 'Orofacial Myofunctional Evaluation with scores' protocol.
Orofacial strength	measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)	Lip and tongue strength measured with the Iowa Oral Performance Instrument.
Sleep: PSG	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)
Quality of Life outcomes: CHQ-PF28	measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)	Child Health Questionnaire (CHQ-PF28)
Sleep: PSQ	measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)	Score on the Pediatric Sleep Questionnaire
Sleep: BSQ	measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)	Score on the Berlin Sleep Questionnaire

Trial Locations

Locations (1)

Ghent University; 🇧🇪 Gent, Belgium