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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Behavioral: Orofacial myofunctional therapy with autofeedback


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Block randomization to ensure 40% female participants. Intervention: Access to treatment module in application plus access to OMT therapist. Control: Access to application without treatment module. No scheduled appointments with OMT therapist.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Application plus treatment module<br>The following exercises are pre-recorded and presented in the treatment module: Tongue Tongue brushing Tongue sliding Tongue suction Tongue down Soft palate 1. Elevate soft palate and uvula 2. Balloon blow Facial Put your finger in the oral cavity against your cheek. Pull against your finger with the cheek muscles. Air pump Exercise adherence is registered in a study application | Behavioral: Orofacial myofunctional therapy with autofeedback<br>* 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.<br>|
| No Intervention: Application awaiting access to treatment module<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea hypopnea index reduction | Measured by self-applied somnography. The index represents number of apneas or hypopneas per hour from 0/h. Higher values represents more severe disease. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Epworth Sleepines scale | The scale is a validated tool measuring sleepiness between 0-24. Higher values represent more sleepiness | 3 months | 
| Orofacial myofunctional therapy adherence | Measured by application registration between 1-3 per day. Three exercises per day is the maximum score | 3 months | 
| Change in desaturation severity parameter measured by medical device | Measured by photoplethysmography obtained by self-applied somnography. More severity represents more disease. | 3 months | 
| Change in desaturation duration measured by medical device | Measured by photoplethysmography obtained by self-applied somnography. Longer duration represents more disease. | 3 months | 
| Change in objective sleep quality | Measured by self-applied somnography. Sleep quality is the ratio between total sleep time and time in bed. A higher ratio is better. | 3 months | 
| Change in desaturation severity parameter measured by wearable | Measured by photoplethytsmography obtained by Withings Scan Watch. More severity represents more disease. | 3 months | 
| Change in desaturation duration measured by wearable | Measured by photoplethytsmography obtained by Withings Scan Watch. Longer duration represents more disease. | 3 months | 
| Change in stroop test | Measured by Flexibility game in application. More correct answers is better | 3 months | 
| Change in reaction test | Measured by reaction game in application. Shorter reaction time is better | 3 months | 
| Change in memory test | Measured by memory game in application. Longer sequences memorized is better | 3 months | 
| Change in perception test | Measured by perception game in application. More correct answers is better. | 3 months | 
| Change general health status | Measured by a visual analogue scale in the BEAMER questionnaire, two visio analogue scales on general health and 3 items on acceptance and control scored 1-6 respectively. | 3 months | 
| Changes in the Orofacial Myofunctional Evaluation with Scores | Measured by scorer blinded for randomization. Range 37-103. A lower score represents more dysfunction. | 3 months | 
| Changes in tongue strength | Objective strength measured by the Iowa Oral Pressure Inventory. A higher score represents more strenght. | 3 months | 
| Changes in tongue endurance | Objective endurance measured by the Iowa Oral Pressure Inventory. A higher score represents more endurance. | 3 months |