NCT06079073

The Effect of Orofacial Myofunctional Therapy With Autofeedback on Obstructive Sleep Apnea

The Effect of Orofacial Myofunctional Therapy With Autofeedback and the Effect of Anatomical and Behavioral Variables on Adherence to Orofacial Myofunctional Therapy in Patients With Mild or Moderate Obstructive Sleep Apnea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: University Hospital, Akershus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of this study is to estimate the effect of orofacial myofunctional therapy (OMT) plus auto-monitoring compared to auto-monitoring alone. Moreover, the investigators aim to identify anatomical and behavioural predictors of OMT adherence

Detailed description

The overall aim will be addressed by reqruiting 100 participants to orofacial myofunctional therapy. 50 will be randomized to immediate treatment after the baseline consultation while 50 will get access to the treatment module after 3 monts of waiting. Outcomes will be assessed by a researcher blinded for the randomization result.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
BEHAVIORAL	Orofacial myofunctional therapy with autofeedback	Participants opening a code unlocking the OMTa treatment module of the application will be given a direct communication link to the PhD students, Diana Hansen (Norway) and Andres Koster (Estonia) and two research co-ordinators. Dr. Hansen and Andres Köster has obtained an Academy of Orofacial Myofunctional Therapy (AOMT) certification diploma. One physical start up session will be scheduled at Ahus and at North Estonia Medical Center. This 60 minute session will be used to instruct participants in OMT exercises and use of the app. All participants will receive a disposable toothbrush and standardized balloons. After that, biweekly video sessions (time 20-30 min) will be scheduled.

Timeline

• Start date: 2023-08-29
• Primary completion: 2025-03-29
• Completion: 2025-03-29
• First posted: 2023-10-12
• Last updated: 2025-04-01

Locations

2 sites across 2 countries: Estonia, Norway