Oromyofunctional Training: an Innovative Rehabilitation Program for Pediatric Obstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity Ghent
About this trial
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. However, adenotonsillectomy, the standard therapeutic approach for children with OSA, is often inadequate. Research shows that 20-40% of children still have residual OSA symptoms after surgery. Therefore, exploring other treatment options, specifically for those patients who currently have insufficient therapeutic options, 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 obstructive sleep apnea (OSA). 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged between 6-12
Diagnosed with Obstructive Sleep Apnea on Polysomnography (AHI<1)
Disqualifiers
History of Orofacial Myofunctional Therapy
Undergoing an orthodontic procedure during the study period
Undegoing an OSA treatment during the study period
Orofacial congenital deformities
Trial design
Design model
Single group
Treatments tested in this trial
Orofacial myofunctional therapy
BehavioralOrofacial 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.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: OSA-patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sleep: change in OAHI
Obstructive apnea hypopnea index measured by polysomnography
Time frame
measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)Secondary outcomes
1
Orofacial Myofunctional Outcomes: OMES score
Score on the 'Orofacial Myofunctional Evaluation with scores' protocol.
Time frame
measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)2
Orofacial strength
Lip and tongue strength measured with the Iowa Oral Performance Instrument.
Time frame
measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)3
Quality of Life outcomes: CHQ-PF28
Child Health Questionnaire (CHQ-PF28)
Time frame
measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)4
Sleep: PSQ
Score on the Pediatric Sleep Questionnaire
Time frame
measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov