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

NCT ID: NCT06079073

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-29
• Study Completion Date: 2025-03-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Application plus treatment module

The following exercises are pre-recorded and presented in the treatment module:

Tongue

1. Tongue brushing

2. Tongue sliding

3. Tongue suction

4. Tongue down Soft palate

1. Elevate soft palate and uvula 2. Balloon blow Facial

1. Put your finger in the oral cavity against your cheek. Pull against your finger with the cheek muscles.

2. Air pump Exercise adherence is registered in a study application

Group Type: EXPERIMENTAL

Orofacial myofunctional therapy with autofeedback

Intervention Type: BEHAVIORAL

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.

Application awaiting access to treatment module

Participants receiving a code not unlocking the treatment module will have full access to all other parts of the mobile app. After 90 days, during the outcome evaluation, all participants will receive a new code unlocking the treatment module in order to keep outcome evaluators blinded.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients referred to Ahus or the Fertilitas clinic

• A diagnosis of obstructive sleep apnea according to the current International Classsification of Sleep Disorders (ICSD) version 3 criteria {Berry, 2020, The AASM Manual for the Scoring of Sleep and Associated Events: Rules', Terminology and Technical Specifications', Version 2.6.;, 2014, International classification of sleep disorders', 3rd ed.}, with a respiratory event index (REI) <30.
• Not previously or currently treated with PAP or MAD
• Signed informed, written consent.
• Owning a mobile phone with software compatible for the study application Age ≥18 year.
• Body mass index <30
• Ability to breathe through the nose
• Ability to read and willingness to follow the protocol as described in the written consent form
• Teeth 5-to 5 should be present or fixed by prosthesis or implants.
• No botulinium toxin in facial muscles last three months

Exclusion Criteria

• Failure to fill in at least 70% of days in the electronic sleep diary provided in the mobile app for two weeks.

• Medical or psychiatric conditions which may interfere with the study protocol in the opinion of the investigator. Examples are acute psychosis, drug abuse and dementia. This will be noted in the study inclusion-exclusion document for each approached candidate for the study. The information will then be discussed in an exlusion committee consisting of dr. Skirbekk, Jagomägi, Dammen and Hrubos-Strøm.
• Tongue-tie as described below. Participants with mouth opening of <50% with the tip of the tongue at the incisive papilla compared to total mouth opening will be excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Oslo Metropolitan University

OTHER

Sponsor Role: collaborator

University of Tartu

OTHER

Sponsor Role: collaborator

Reykjavik University

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Harald Hrubos-Strøm

MD, PhD, senior consultant and head of research group, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harald Hrubos-Strøm, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

Fertilitas clinic

Tallinn, , Estonia

Akershus University Hospital

Lørenskog, Akershus, Norway

Countries

Estonia; Norway

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

22/11571

Identifier Type: -

Identifier Source: org_study_id