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
Phase: NA
Conditions: Sleep Apnea, Obstructive
Sponsor: University Hospital, Akershus

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Project “Sleep Revolution” 
Clinical investigation plan for the study:  
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 (OMTAOSA) 
 
 
 
Researchers  
Diana Dobran Hansen Dentist, dental hygienist, PhD student, Akershus 
University Hospital, Institute of Clinical Medicine, Medical Faculty, University of 
Oslo 
 
Helge Skirbekk, PhD, MSc; Researcher, Institute of Clinical Medicine, Medical 
Faculty, University of Oslo; Professor of Health Literacy, OsloMet University, 
Faculty of Health Sciences, Department of Nursing and Health Promotion 
 
Toril Dammen MD PhD, Professor of Psychiatry, Institute of Clinical Medicine, 
Medical Faculty, University of Oslo 
 
Xin Feng, PhD, Post doc researcher, University of Oslo, Institute of Clinical 
Medicine, Medical Faculty, University of Oslo 
 
Hanna Mäkinen, Chief specialist of myofunctional therapy, University of Tartu, 
Estonia 
 
Unn Tinbod,  Speech-language pathologist, Akershus University Hospital 
 
Andres Köster, Speech-language pathologists, orofacial myofunctional therapist, 
North Estonia Medical Centre. PhD student University of Tartu, Estonia 
 
Heisl Vaher, MD, somnologist, ENT doctor at Fertilitas Private Hospital 

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Triin Jagomägi, DDS, PhD, Associate professor in orthodontics, University of 
Tartu, Estonia 
 
Harald Hrubos-Strøm, MD, PhD, senior consultant Akershus University 
Hospital, division of surgery, Department of Otorhinolaryngology and associate 
professor University of Oslo, Faculty of medicine, Institute for clinical medicine, 
Campus Ahus, clinic of surgical research 
1 Background 
1.1 Obstructive Sleep Apnea (OSA) in a clinical context 
Sleep apnoea is a common disorder in the Norwegian, adult population. A 
Norwegian study has estimated the prevalence of OSA defined by an Apnoea 
Hypopnea Index (AHI) of ≥ 15 to be 8 % among adults aged 30-65 years 1. If 
untreated, OSA is associated with increased risk of cognitive impairment, 
cardiovascular morbidity, mortality and daytime sleepiness 2.  
 
Treatment with positive airway pressure (PAP) has been shown to reduce 
cardiovascular risk, to relieve symptoms and to be cost-effective in patients with 
moderate to severe OSA 3. However, approximately 25% do not adhere to 
treatment and patients who adhere uses the machine less than prescribed 4. 
Complementary, less efficient treatment modalities for OSA are: Lifestyle change 
5, positional therapy 6, mandibular advancement devices (MAD) 7 and surgery 8.  
 
Treatment with PAP is cumbersome. Accordingly, in mild to moderate OSA novel 
treatment options are warranted 9. Orofacial myofunctional therapy (OMT) has 
in a recent Cochrane report been shown to be effective in mild to moderate OSA 
10. However, more randomized controlled trials (RCTs) with blinded assessment 
of end points and intention to treat design are needed. Auto-monitoring through 
participatory health technology is a promising method for the increase of 
treatment adherence11. 
Aims and hypotheses 

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2.1 Overall research aims 
The overall aim of this study is to estimate the effect of OMT plus auto-
monitoring (OMTa) compared to auto-monitoring alone.  Moreover, we aim to 
identify anatomical and behavioural predictors of OMTa adherence. 
3.0 Material and methods  
The study is a single blinded RCT with blinded outcome evaluation and 
intention to treat analysis. The participants will know by default if they are 
allocated to the OMTa or waiting list with auto-monitoring during the 90-day 
intervention period. Blinded baseline- and outcome assessments will be 
performed by one doctor (Dr Feng) in Norway and one doctor (Dr Vaher) in 
Estonia. 
3.1 Material 
Patients referred to the Otorhinolaryngology department at Akershus University 
Hospital (Ahus), Norway and the Fertilitas Private Hospital (FPH) in Tallinn, 
Estonia. Eligible patients with a suspected or confirmed diagnosis of OSA will be 
asked to participate in this RCT. An informed consent form will be given or sent to 
the participant together with information to log in to the mobile application (app). 
The mobile app contains an electronical sleep diary based on the consensus sleep 
diary (appendix 1).  
 
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 

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• 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.  
Inclusion criteria will be assessed by the otorhinolaryngologist establishing an 
OSA diagnosis or the project co-ordinators.  
3.2 Methods 
Prior to the baseline consultation 
All participants will receive a standardized information sheet with login 
information to the electronic sleep diary. Support on using the application prior 
to the baseline evaluation will be available by the study co-ordinators by 
telephone. Evaluation of exclusion criteria will be assessed prior to- or at the 
baseline study visit. Excluded patients will be referred back to clinical care. Signed 
informed consent will be obtained and archived on paper. 

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Baseline evaluation 
Eligible candidates completing auto-monitoring less than 70% of the days prior to 
baseline assessment will be excluded (see exclusion criteria above). Questions 
related to the “Sleep Well” application will be answered. Dr. Feng and Dr. Vaher 
respectively will also ensure that at least 40 of 100 participants are female. After 
final inclusion, Dr. Feng and Dr Vaher respectively will schedule the sleep 
registration and an outcome evaluation session 90 days later. All data collected 
during the baseline evaluation will be collected in the “Redcap” case report form 
(CRF).  
 
Further, clinical evaluation will consist of height, weight, standardized blood 
pressure and a breath holding test 12. Digital oral scanning will be obtained at both 
sites. Thereafter, the quantitative scores (OMES) for assessing the myofunctional 
therapy will be performed and video filmed with one front camera and one camera 
with a 45-degree angle on the face. The purpose of the video filming is inter rater 
reliability analyses. All participants will be placed in a chair without arm- or 
backrest. Body posture on the chair will not be corrected. The baseline assessment 
will last approximately 90 minutes. 
Baseline assessment includes: 
o OMES-protocolAppearance/Posture: face (symmetry), cheeks, 
mandible, lips, tongue and hard palate. Mobility: Subjects will be 
asked to perform 4-6 movements with each component of lips, 
tongue, cheeks and mandible.  
o Functions: breathing mode, deglutition and mastication.  
o The maximum possible score for functions will be 29 (breathing=3, 
deglutition=16, mastication= 10).  
o Tongue movement described in the OMES protocol.  
• Additional tongue assessment: Evaluation of tongue tie using the quick-
tongue tie assessment tool for measurements of Maximal interincisal 
mouth opening (MIO, mm) and interincisal mouth opening with tongue tip 
to maxillary incisive papillae at a roof of the mouth (MOTTIP) .  

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• Oral scanning: 3D dental scanning will be performed at both sites. 
Pseudonomized electronic files will be analyzed with the “Dolphin®” software 
(Dolphin Ceph Tracing | Dolphin Imaging Software) in Estonia.  
• Height measurement: The participant will be asked to stand barefoot in an 
upright position with their heels, buttocks, and upper back up to the wall and 
their head facing directly ahead. Feet together and arms by the sides. The 
distance from the floor to the highest point of the head will be measured by the 
nearest 0.1cm. The total height (cm) will be recorded.  
• Weight measurement: The participant will be asked to step barefoot on a stand-
alone unit with a digital scale. The Body mass will be measured with an 
accuracy of 100g. Participants will be asked to remove shoes and socks as well 
as heavy jumpers/jackets/jeans. The total weight (kg) will be recorded.  
• Body Mass Index (BMI): BMI will be calculated by the formula of body mass 
(kg) divided by height squared (m2) (kg/m2)   
• Waist Hip Ratio: Waist and hip circumference will be assessed in manual 
measurements with flexible but non-stretchable tape with an accuracy of 1mm. 
The waist circumference will be measured at the midpoint between the last rib 
and the Iliac Crest. The hip circumference will be measured at the level of the 
largest lateral extension of the hip. Both measures will be assessed in the 
horizontal plane. The waist and hip circumference will be recorded and the 
Waist Hip ratio will be calculated using the formula of waist circumference 
divided by hip circumference.   
• Neck Circumference: Neck circumference will be measured with a flexible but 
non-stretchable tape measure with an accuracy of 1mm. The neck 
circumference will be measured in the midway of the neck, between the mid-
cervical spine and mid-anterior neck. The subject will be asked seat relaxed with 
the arms hanging by their side and to maintain the head in the Frankfort 
Horizontal plane. For men, the measure will be taken immediately superior to 
the Thyroid cartilage (Adam‘s apple). The total neck circumference will be 
recorded (cm).   
 
Hand grip strength13 assessed by hand dynamometry of the dominant hand will 
be evaluated with a Jamar hand dynamometer (Jamar Hydraulic Hand 
Dynamometer (5030J1) | JLW Instruments (jlwforce.com)). The grip strength 

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will be measured in a face-to-face assessment with the participant sitting on a 
chair with a back support and fixed arm rests, feet on the ground. Their wrist 
should be just over the end of the arm rest, with the thumb facing upwards. The 
examiner should encourage the participant to squeeze as long and as tightly as 
possible until the needle stops rising. The measurement from the dial should be 
recorded to the nearest 1kg. If the participants arm rises above the chair the 
measurement should be disregarded. Three measurements will be recorded for 
each hand, while alternating sides (Procedure for measuring gripstrength using 
the JAMAR dynamometer (uhs.nhs.uk)). 
 
Chewing test 
A standardized chewing efficiency test is performed with the CHEW Box Digital 
Reporting services (DRS CHEW box) from Orehab Minds (https://www.orehab-
minds.com/). The patient is instructed to perform 9 chewing sequences with 
standardized gelatin test units of soft, medium and hard consistency. Each 
sequence consists of chewing for 30 seconds with 30 seconds intermission, first 
only on the right side, next only on the left side and last on both sides, alternating 
every 5 seconds. Participants will be instructed to “divide as many pieces as you 
can”. The chewed-up pieces of the test unit are spitted out in a sieve, rinsed and 
distributed on a plate which is placed inside the DRS CHEW box. The box takes a 
picture with standardized lighting, angle and camera distance. The 9 pictures 
from each chewing test are uploaded to a central database where they are 
analyzed. No identifying patient data is stored in this system. This results in a 
report where number of particles, average size, and distribution ratio of particle 
size is calculated. A comparison of chewing efficiency differences between sides 
and consistencies is presented both graphically and numerical, and is compared 
to a normal distribution for healthy adults. 
 

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The Iowa oral performance instrument (IOPI), https://iopimedical.com/, is used to 
measure the pressure of anatomical structures in the oral cavity. The calibration of 
the device was tested against another device in January 2022. Tongue strength will 
be assessed at baseline and after 12 weeks of OMTa. The subject will be instructed 
to place and press a disposable, standard-sized bulb as hard as possible with the 
tongue against the roof of the mouth for 2–3 seconds. The maximum pressure is 
demonstrated as tongue strength in kilopascals (kPa). After obtaining the measured 
value, the measurement will be repeated two additional times and the highest value 
will be scored. In addition, the subject will be instructed to maintain 50% of the 
highest pressure as long as possible. The maintained duration of time will be 
recorded as tongue endurance.  
 
Lateral cephalography is applied to assess the oral maxillofacial anatomy. 
Participants are asked to relax their face and mouth, keep the teeth in centric 
occlusion, swallow once and hold the tongue in the position. The cephalograms 
are taken at 73 kVp and 15 mA, in natural head position with the patinet’ sagital 
plane parallel to the X-ray film and the Frankfort plane parallel to the floor. Dr. 
Feng will trace all the required landmarks on the cephalograms. This preliminary 
cephalometric study mainly focuses on anatomical variables related to OSA. Four 
variables related to tongue morphology will be registered. In addition, hyoid 
position will be represented by the distance between the hyoid bone and the 
mandibular plane. 
Patient reported outcomes collected during baseline evaluation:  
The BEAMER questionnaire is being developed in a current, large study funded 
by the innovative medicines initiative. The core version consists of one visual 
analogue scale assessing general health, three questions assessing control and 
three questions assessing acceptancy.  
 
The Epworth sleepiness scale (ESS) is a 8-item measure of daytime sleepiness. 
The questionnaire has been validated in a Norwegian population14.  
 

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The physical health questionnaire (PHQ) is a 9-item measure of depression15. 
The questionnaire has been validated in a Norwegian population 16.  
 
The General anxiety Disorder (GAD) questionnaire is a 7-item measure of anxiety 
17. The questionnaire has been validated in a Norwegian population 18. 
 
The DS-14 questionnaire is assessing type D personality. The questionnaire has 
been validated in the Akershus Sleep Apnea Project 19,20. 
Wearable technology  
All participants will be asked to wear a Withings Scanwatch, 
https://www.withings.com/be/en/scanwatch, programmed in research mode. 
The research mode setting implies that the watch operates as a sensor.   The 
patients can monitor their own sleep quality data inside the Withing's mobile 
application. Participants will be instructed to open the Withings application 
daily. 
Randomization 
At the end of the baseline consultation participants will be randomized to either 
OMTa or only auto-monitoring. Block-randomization with 10 lots per block, per 
study site, and a 50/50 allocation ratio will be used for waiting list and 
intervention and separated by sex in order to monitor the 40/60 gender balance. 
The lots will be made as a code on paper and concealed in opaque envelopes at 
each study centre. Each participant will also receive a unique e-mail address and 
a password in the same envelope. The randomization envelopes will be made and 
mixed by dr. Feng. Envelopes will be sent to dr Vaher in Estonia. Both researchers 
will be blinded for the content in the envelopes.  
After baseline evaluation:  
Polysomnography (PSG) 
All patients, both intervention and waiting list group, will administer three nights 
of self-applied PSG (hereinafter called SAS). This is an alternative to in-lab services 
and PSG setups, in a self-applied form. The EEG is located only on the forehead (F-
channels), with no electrodes located on the top of the scalp (C-channels) and back 
of the head (O-channels) as in traditional PSG21. The self-applied setup facilitates 

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the use of multi-night studies to capture night-to-night variability and the 
participants apply the sensors themselves, using an instructional video provided 
by Nox. In this study, we will do three nights in a row twice. PSG will be performed 
before the baseline consultation and before the outcome evaluation. The 
equipment will be given out at baseline consultation. After use the patients will 
mail the equipment back to Ahus/FPH or bring the equipment back to the first 
treatment session.  
Outcome variables derived from polysomnography 
The desaturation severity parameter (Des Sev) was introduced by Kulkas et al in 
2013 22. We have recently validated this variable with traditional variables such 
as the AHI, oxygen desaturation index, time below 90% saturation and nadir 
saturation, all assessing OSA severity 23. 
 
Sleep efficiency (SE) will be calculated as the scored total sleep time divided by 
the total sleep period (TST). TST is defined as time from “lights out” to “lights on” 
divided by scored total sleep time. Sleep will be scored in accordance with the 
current version of the American Academy of Sleep Medicine (AASM) manual 
(version 2.6, 2020)24. The scoring will be done by expert sleep technologists at 
Reykjavik University Sleep Institute, using Noxturnal Research (version 
6.1.0.30257). The following adjustments are needed for the SAS 
electroencephalography (EEG) signal: 
-The low pass filter setting for the EEG will be changed from 0.3 Hz to 0.5 Hz. 
-The peak to peak amplitude of the slow wave activity will be changed from 75 
µV to 50 µV. Moreover, in the standard PSG, signals are measured over the 
frontal regions and referenced to the contralateral ear or mastoid (F4-M1, F3-
M2). In the SAS it is referenced to the average of E4 and E3. The frontal filter 
available in the software will not be used. 
-The frontal electromyography (EMG) does not show loss of tone in REM in the 
same manner as chin EMG. This means that REM rules that refer to chin tone are 
not useable for the most part.  But it is however possible use the EMG frontalis to 
aid in scoring arousals (in rapid eye movement (REM) in particular). Arousals in 
REM will be scored if there is an abrupt change in the EEG to faster frequencies 
accompanied by an increase in EMG tone as in the AASM scoring rules. 

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Participatory health technology 
The auto-monitoring application is named “Sleep Well”. The application 
communicates with a data cluster located in Iceland. The Sleep Well application 
contains a sleep diary25. The diary is inspired by the consensus sleep diary 
developed by Carney and co-workers (appendix 1)26. Subjective, quantitative 
sleep data including sleep efficiency will be calculated based on the formulas 
proposed by Reed and co-workers 27. Exercises will be reported in an exercise 
diary in the sleep well application. A simple question for each of the three daily 
exercises will be delivered. Adherence to exercises will be assessed by the 
number of entries to the three daily questions. Administrative co-ordinators will 
support participants with technical issues.  
Patient reported outcomes (PROMs) delivered by the “Sleep Well” application 
The European sleep questionnaire is being developed in the Sleep Revolution 
project. A prototype of the questionnaire has been uploaded as a separate 
attachment.  
Neuropsychological tests delivered by the “Sleep Well” application 
 Within the SleepWell application there are four cognitive tests which combined 
cover the major cognitive domains which are affected by sleep disorders. The 
data from these, will be in the same manner as other data from the SleepWell 
app, be transferred to the Sleep Revolution data storage within Reykjavik 
University in Iceland. The  four cognitive tests are: i) Inspection Time Test; ii) 
Psychomotor Vigilance Test; iii) Corsi Block Test, and; iv) Stroop Test. In the 
following, we will go through each to provide a short overview of its purpose. 
  
Inspection Time Test 
The Inspection Time Test is another neuropsychological test to measure 
processing speed, perceptual speed, and selective attention. As this test is 
independent of motor speed, it is therefore applicable for testing participants with 
motor impairment. In the Inspection Time Test, the participant is presented with 
a stimulus with a long and short arm. Stimulus presentation duration is varying 
across trials. After every stimulus presentation, the stimulus is covered by a mask, 

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and the participant has to decide whether the short arm was on the left or right 
sight by pressing the corresponding response keys. The participant is instructed 
that the reaction time does not matter. This test is successfully and widely used. 
  
Psychomotor Vigilance Test 
This tests measures vigilance. Participants are instructed to press a key as soon as 
the target appears on the screen and get feedback about their reaction time or an 
error message if an in invalid response was given. Vigilance is one of the most 
affected domains by sleep disorders indicated by a large effect size. Further, 
impaired vigilance leads to impaired executive control. The Psychomotor 
Vigilance test is one of the most sensitive measurements for the impact of sleep 
deprivation on neurocognitive functioning. This test is presented within the app. 
  
Corsi Block Test 
The Corsi Block tests are measurements of executive functions, more precisely 
working memory. The participant is presented with 9 boxes, which light up in 
specific sequence. Participants are asked to repeat the sequence. The test starts 
with 2 boxes and constantly increases the number of boxes. The participant has 2 
chances for each sequence length. If one of the sequences was entered correctly, 
the next sequence is presented. If both of the sequences were entered incorrectly, 
the experiment ends. In the forward version, the sequence has to be repeated in 
the exact same order as presented. In the backwards version, the sequence is to 
be repeated in the reversed order. The Corsi Block tests are one of the most 
frequently used tests for evaluating the impact of sleep disorders on working 
memory and are therefore studied intensely in research on working memory. This 
test is presented in the app. 
  
Stroop test 
The Stroop test is a frequently used test for measuring inhibitory control, selective 
attention, and cognitive flexibility. It requires the subject to inhibit an unwanted 
response, and direct the attention to the task-specific goal. The test consists of 
three parts: In the first part, the subject is asked to read the words "green", "red", 
"blue", and "yellow" and the reading speed is measured. In the second round, the 

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colors are presented as blocks and the participant needs to name the correct color. 
In the last part, a color word is presented in another color, creating an incongruent 
condition. Here, the participant is instructed to name the color of the word and 
suppress naming the written word. Reliability and validity of this test are good. In 
the context of sleep disorders, the Stroop test showed worse performance in 
patients with OSA. and insomnia and is therefore a good addition to this study. 
This test will be available in the app. 
The completion of the tests will be voluntary in this study. Participants will be 
asked to perform the tests three times during the 90 day study period. 
 
Description of the intervention  
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. 
The exact same amount of sessions and equipment will be offered to the waiting 
list group after the outcome evaluation. The following exercises are pre-recorded 
and presented in the treatment module:  
 
Tongue  
1. 
Tongue brushing: Brush the superior and lateral surfaces of the tongue 
while fixing the tongue in different positions of the mouth. Repeat each 
movement for five times, three times a day for 14 days.  
  
2. 
Tongue sliding: Place the tip of the tongue against the hard palate 
behind your upper front teeth. Slide the tongue backwards along hard palate. 
Repeat 20 times, three times a day.  
  
3. 
Tongue suction: Suck the entire tongue upwards against your hard 
palate and press upwards. Both short and long pressure intervals. Repeat 20 
times short, 20 times long, three times a day.  
  

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4. 
Tongue down: Force the back of the tongue down against the floor of 
the mouth. Keep the tip of the tongue in contact with the lower front teeth. 
Repeat 20 times, three times a day.  
  
Soft palate  
1. 
Elevate soft palate and uvula whilst saying ”ah” both intermittently (”a 
-a -a”) and continuously (”aaa”).  Repeat 20 times, three times a day. 
2. 
Balloon blow: Inhale through your nose, blow into a balloon with 
force. Don´t take the balloon off your mouth and repeat blowing for five 
times, three times a day.If socially not acceptable to blow the balloon, blow air 
through pressed lips five times. Please blow the balloon in the morning and 
evenings.  
  
  
Facial  
1 Put your finger in the oral cavity against your cheek. Pull against your 
finger with the cheek muscles. Repeat 10 times on each side, three 
times a day. If socially not acceptable to put the finger in the mouth, 
blow air from cheek to cheek. Please use finger in the morning and 
evenings.  
2 Air pump: Blow air against your cheek while alternating sides. Keep 
lips closed. Repeat 10 times on each side, three times a day.  
 
 
The list of exercises is a revised version of the protocol published by Guimaraes et 
al in 2009 {Guimaraes, 2009, Effects of oropharyngeal exercises on patients with 
moderate obstructive sleep apnea syndrome@@shared-groups}. Time per set of 
exercise is 10-15 minutes. The intervention will be ongoing for three months (12 
weeks). Progression in exercises, subjective sleep parameters and treatment 
adherence will be evaluated in video sessions with the PhD students at respective 
locations. Problems will be solved with joint video sessions with the participant, 
the PhD student and an experienced OMT therapist.  
Description of waiting list, auto-management condition 
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.  
 

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Outcome evaluation 
At outcome evaluation (estimated time 60 minutes), Dr. Feng (Norway) and dr. 
Vaher (Estonia) will repeat the following assessment from the baseline 
evaluation:  A clinical evaluation will consist of height, weight and standardized 
blood pressure. Thereafter, the quantitative scores (OMES) for assessing the 
myofunctional therapy and patient reported outcomes will be repeated (see 
above). Finally additional repeated diagnostics with the hand dynamometer, chewing 
test and IOPI will be repeated. All data will be collected in the “Redcap” CRF.  
Finally, each participants will be given a maximum of five feedback questions. The 
exact phrasing of the questions will be finalized when answers to similar 
questions in a pilot study have been analysed. The brief interview will be audio 
taped and transcribed. 
Outcomes 
The primary end point of the RCT is change in the AHI 
 
Secondary endpoints:   
1. 
Change in the Epworth Sleepines scale and PROMs in the European Sleep 
Questionnaire. 
2. 
OMTa adherence 
3. 
Change in other conventional OSA severity indices (oxygen desaturation 
index, time below 90% saturation, nadir saturation) and change in novel OSA 
parameters in SAS identified in the development phase of the project. 
4. 
Change in objective and subjective sleep quality (PSG and sleep diary, 
respectively). 
5. 
Change in physiological parameters assessed by wearables. 
6. 
Change in objective daytime functioning testing (PVT and Stroop test). 
7. 
Change in self-reported self-efficacy as assessed by the PAM. 
8. 
Changes in the Orofacial Myofunctional Evaluation with Scores (OMES). 
9.  
Changes in the IOPI strength and endurance 
10.  
Changes in hyoid position as assessed by a lateral cephalogram 
11. 
Prediction of improvement in SDB severity by objective parameters from 
a 2D cephalogram obtained at baseline. 

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5 Procedures 
5.1: Responsibility 
Participants of the study will be transferred from regular clinical practice to the 
research project for 90 days. During this period, the national project leader is 
medically responsible. Breaches of the protocol will be systematically addressed 
and reported to a hospital appointed monitor at the division of surgery. After the 
90 days outcome evaluation, all participants will allocated to an open label 
follow-up condition. The frequency of follow-up consultations is dependent on 
future funding. During follow-up, participants of the waiting list, auto-
management condition will be offered up to 10 video recordings free of charge 
with the PhD student. All participants will have unlimited access to the auto-
monitoring platform and the intervention module during follow-up.  
 
Cumulative safety information 
OMT consists of exercises of tongue / lip muscle. There is no physical injury recorded but 
the therapy involves the use of time for training. Patients who will not master or have the 
effect of treatment may experience this as a burden.  
 
Cumulative efficacy information 
The concept of orofacial myofunctional disorders (OMD) refers to the abnormal 
resting posture of the orofacial musculature, atypical chewing, and swallowing 
patterns, dental malocclusions, mouth breathing, blocked nasal airways, and 
speech problems This novel paradigm defines OSA as an OMD developing from 
early childhood. OMT aims to re-educate the movement of muscles, restore 
correct swallowing patterns, and establish adequate labial-lingual postures.  
 
Recent systematic reviews of the effect of OMT on OSA conclude that OMT as a 
participatory health intervention is promising as mono therapy in mild to 
moderate disease, and as an adjunct to other therapies in moderate to severe 
disease. However, the need for further studies is also highlighted due to the small 

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number of studies available, heterogeneity of interventions and high risk of bias 
with low quality of evidence 9,28,29.  
5.2 Time frame 
Data will be collected from August 2023 until August 2024.  
6 Statistical analysis plan and power calculation 
OMTa adherence will be dichotomized by performance of ≥85% of exercises in 
three domains based on the electronic exercise diary. Patients non fulfilling these 
criteria will be classified as OMTa non-adherent30. Results will be analysed as 
intention to treat regardless of OMTa adherence.  
6.1 Statistical analysis 
The Kruskal-Wallis test will be used for intergroup comparisons at each time 
point (T1 and T2). Intragroup comparisons will be performed by the Friedman 
test.  
Inter-examiner agreement of OMT measurements will be determined by 
intraclass correlation coefficients (ICCs) and weighted kappa coefficient (Kw’). 
Effect sizes for statistically significant differences between T1 and T2 will be 
calculated using the Cohen’s d statistic.  
6.2 Power calculation 
The number in each group is calculated to N=50 based on the results of 
Guimaraes et al30. The AHI was used in the calculation. 
Independent samples t-test, two-sided, anticipated effect size (Cohen’s d) 0.8 
(high), power ≥80%, probability level 5%. This gives a minimal sample size of 26 
per group. The expected drop out of patients during the OMTa trial is 25% 
corresponding to a total of 20 patients. To accommodate for this potential 
dropout and to have adequate power for subpopulation analysis for gender, the 
sample size was increased  to 100 (50 in each group). 
7 Costs/finance 
Horizon 2020, grant number 965417  

CIP OMTAOSA RCT version 230808 
 
 
 
8 Ethical aspects 
Study management, study monitoring, data and sample management 
The study site will have a designated study coordinator and ethical guardian who 
will be appropriately trained and informed about the nature of the study, ethical 
and data security aspects; including informed consent, good clinical practice (GCP) 
and applicable regulatory requirements.  
 
All clinical patient source data will be stored at the hospital according to clinical 
routines. The project leader will be responsible for the “code key” with which it is 
possible to connect the data to the patient and this data will be kept offline.  
 
Regulatory / ethics status 
The following directives will be applied: Good Clinical Practice (GCP) rules 
according to the declaration of Helsinki.  
 
The ASAP Clinical Cohort has appointed a user representative from the 
Association for Sleep Disorders in Norway. The same representative will be 
invited to provide end user feedback in this study.  
   
9 Spread of results, international collaboration and end 
of project 
Results will be published in international, peer reviewed medical journals in 
accordance with the international committee of medical journal editors (ICMJE) 
criteria, https://www.icmje.org/. The international collaborators, Hanna 
Mäkinen and Triin Jajomägi are involved in training and supervision of the PhD 
student respectively. They will be involved in data analysis inside the Tjenester 
for Sensitive Data (TSD) platform. The project will end on February 28th 2025, 
data will be stored for an additional 5 years. 

CIP OMTAOSA RCT version 230808 
 
 
10 Appendix 
1 Paper version of sleep diary 
 
 
 
 
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