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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2027-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT07129967

Obstructive Sleep Apnea (OSA) Orofacial Myofunctional Disorders

RECRUITING NA

Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome

NCT07195253

Obstructive Sleep Apnea Down Syndrome (Trisomy 21)

NOT_YET_RECRUITING

Effect of Myofunctional Therapy on OSA

NCT04608552

Obstructive Sleep Apnea

COMPLETED NA

Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome

NCT01808508

Down Syndrome Obstructive Sleep Apnea Syndrome

COMPLETED NA

Upper Airway Physical Therapy for the Treatment of Obstructive Sleep Apnea

NCT02109731

Obstructive Sleep Apnea Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea (OSA) Orofacial Myofunctional Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OSA-patients

orofacial myofunctional therapy

Group Type EXPERIMENTAL

Orofacial myofunctional therapy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Orofacial myofunctional therapy

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Oromyofunctional therapy Oropharyngeal exercises

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No