Sleep Apnea, ObstructiveOMTAOSANCT06079073
The Effect of Orofacial Myofunctional Therapy With Autofeedback on Obstructive Sleep Apnea
A study testing Orofacial myofunctional therapy with autofeedback in people with Sleep Apnea, Obstructive, run by University Hospital, Akershus at 2 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Orofacial myofunctional therapy with autofeedback
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 29 Aug 2023to 29 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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
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
Read the 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
- Being tested
- Orofacial myofunctional therapy with autofeedback
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orofacial myofunctional therapy with autofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Application plus treatment module | Experimental | 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 Receives: Behavioral: Orofacial myofunctional therapy with autofeedback |
| Application awaiting access to treatment module | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (15)
Change in the Epworth Sleepines scale
The scale is a validated tool measuring sleepiness between 0-24. Higher values represent more sleepiness
Measured: 3 months
Orofacial myofunctional therapy adherence
Measured by application registration between 1-3 per day. Three exercises per day is the maximum score
Measured: 3 months
Change in desaturation severity parameter measured by medical device
Measured by photoplethysmography obtained by self-applied somnography. More severity represents more disease.
Measured: 3 months
Change in desaturation duration measured by medical device
Measured by photoplethysmography obtained by self-applied somnography. Longer duration represents more disease.
Measured: 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.
Measured: 3 months
Change in desaturation severity parameter measured by wearable
Measured by photoplethytsmography obtained by Withings Scan Watch. More severity represents more disease.
Measured: 3 months
Change in desaturation duration measured by wearable
Measured by photoplethytsmography obtained by Withings Scan Watch. Longer duration represents more disease.
Measured: 3 months
Change in stroop test
Measured by Flexibility game in application. More correct answers is better
Measured: 3 months
Change in reaction test
Measured by reaction game in application. Shorter reaction time is better
Measured: 3 months
Change in memory test
Measured by memory game in application. Longer sequences memorized is better
Measured: 3 months
Change in perception test
Measured by perception game in application. More correct answers is better.
Measured: 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.
Measured: 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.
Measured: 3 months
Changes in tongue strength
Objective strength measured by the Iowa Oral Pressure Inventory. A higher score represents more strenght.
Measured: 3 months
Changes in tongue endurance
Objective endurance measured by the Iowa Oral Pressure Inventory. A higher score represents more endurance.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start29 Aug 2023
- Primary completion29 Mar 2025
- Study completion29 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Oslo Metropolitan University, University of Tartu, Reykjavik University
- Responsible party
- Principal investigator, Harald Hrubos-Strøm, University Hospital, Akershus
- Investigators
- Harald Hrubos-Strøm, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079073
- Sponsor's protocol ID
- 22/11571
- Acronym
- OMTAOSA
- Status last verified
- Mar 2025
- First submitted
- 23 Aug 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed by Regional Ethical Committee
Publications
Koster A, Hoang AD, Dashuk A, Vaher H, Sikk K, Jagomagi T. Effects of Web-Based Orofacial Myofunctional Therapy on Hyoid Bone Position in Adults with Mild to Moderate Obstructive Sleep Apnea: Evidence from an Estonian Substudy of a Randomized Controlled Trial. J Clin Med. 2025 Dec 29;15(1):257. doi: 10.3390/jcm15010257.
PubMed 41517505
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06079073
- Acronym / sponsor ID
- OMTAOSA / 22/11571
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- University of Oslo, Oslo Metropolitan University, University of Tartu, Reykjavik University
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 29 Mar 2025 (actual)
- Study completion
- 29 Mar 2025 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Application plus treatment module | Experimental | Behavioral: Orofacial myofunctional therapy with autofeedbackThe 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 |
| Application awaiting access to treatment module | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients referred to Ahus or the Fertilitas clinic
Key exclusion criteria (3 listed)
- Failure to fill in at least 70% of days in the electronic sleep diary provided in the mobile app for two weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orofacial myofunctional therapy with autofeedbackParticipants 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. | Behavioural | Application plus treatment module |
Primary outcome
Apnea hypopnea index reduction
Time frame: 3 months
Measured by self-applied somnography. The index represents number of apneas or hypopneas per hour from 0/h. Higher values represents more severe disease.
15 secondary outcomes
Change in the Epworth Sleepines scale
Time frame: 3 months
Orofacial myofunctional therapy adherence
Time frame: 3 months
Change in desaturation severity parameter measured by medical device
Time frame: 3 months
Change in desaturation duration measured by medical device
Time frame: 3 months
Change in objective sleep quality
Time frame: 3 months
Change in desaturation severity parameter measured by wearable
Time frame: 3 months
Change in desaturation duration measured by wearable
Time frame: 3 months
Change in stroop test
Time frame: 3 months
Change in reaction test
Time frame: 3 months
Change in memory test
Time frame: 3 months
Change in perception test
Time frame: 3 months
Change general health status
Time frame: 3 months
Changes in the Orofacial Myofunctional Evaluation with Scores
Time frame: 3 months
Changes in tongue strength
Time frame: 3 months
Changes in tongue endurance
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Derived from this study: PubMed 41517505Koster A, Hoang AD, Dashuk A, Vaher H, Sikk K, Jagomagi T. Effects of Web-Based Orofacial Myofunctional Therapy on Hyoid Bone Position in Adults with Mild to Moderate Obstructive Sleep Apnea: Evidence from an Estonian Substudy of a Randomized Controlled Trial. J Clin Med. 2025 Dec 29;15(1):257. doi: 10.3390/jcm15010257.
- Individual participant dataSharing planned: No. Not allowed by Regional Ethical Committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Hrubos-Strøm, PhD principal investigator
University Hospital, Akershus
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orofacial myofunctional therapy with autofeedback in people with Sleep Apnea, Obstructive, run by University Hospital, Akershus at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Estonia, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea hypopnea index reduction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06079073, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.