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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
106
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.
Fertilitas clinic
Tallinn, Estonia
Akershus University Hospital
Lørenskog, Akershus, Norway
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.
Time frame: 3 months
Change in the Epworth Sleepines scale
The scale is a validated tool measuring sleepiness between 0-24. Higher values represent more sleepiness
Time frame: 3 months
Orofacial myofunctional therapy adherence
Measured by application registration between 1-3 per day. Three exercises per day is the maximum score
Time frame: 3 months
Change in desaturation severity parameter measured by medical device
Measured by photoplethysmography obtained by self-applied somnography. More severity represents more disease.
Time frame: 3 months
Change in desaturation duration measured by medical device
Measured by photoplethysmography obtained by self-applied somnography. Longer duration represents more disease.
Time frame: 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.
Time frame: 3 months
Change in desaturation severity parameter measured by wearable
Measured by photoplethytsmography obtained by Withings Scan Watch. More severity represents more disease.
Time frame: 3 months
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Change in desaturation duration measured by wearable
Measured by photoplethytsmography obtained by Withings Scan Watch. Longer duration represents more disease.
Time frame: 3 months
Change in stroop test
Measured by Flexibility game in application. More correct answers is better
Time frame: 3 months
Change in reaction test
Measured by reaction game in application. Shorter reaction time is better
Time frame: 3 months
Change in memory test
Measured by memory game in application. Longer sequences memorized is better
Time frame: 3 months
Change in perception test
Measured by perception game in application. More correct answers is better.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Changes in tongue strength
Objective strength measured by the Iowa Oral Pressure Inventory. A higher score represents more strenght.
Time frame: 3 months
Changes in tongue endurance
Objective endurance measured by the Iowa Oral Pressure Inventory. A higher score represents more endurance.
Time frame: 3 months