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| Name | Class |
|---|---|
| University of Oslo | OTHER |
| Oslo Metropolitan University | OTHER |
| University of Tartu | OTHER |
| Reykjavik University |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Application plus treatment module | Experimental | The following exercises are pre-recorded and presented in the treatment module: Tongue
1. Elevate soft palate and uvula 2. Balloon blow Facial
|
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orofacial myofunctional therapy with autofeedback | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Patients referred to Ahus or the Fertilitas clinic
Exclusion Criteria:
Failure to fill in at least 70% of days in the electronic sleep diary provided in the mobile app for two weeks.
Category "non-binary" possible
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| Name | Affiliation | Role |
|---|---|---|
| Harald Hrubos-Strøm, PhD | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertilitas clinic | Tallinn | 10114 | Estonia | |||
| Akershus University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41517505 | Derived | 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. |
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Not allowed by Regional Ethical Committee
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2023 | Aug 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| OTHER |
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.
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Randomization is conducted at the end of the baseline assessment. Participants in the intervention group is handled by an OMT therapist until outcome assessment by the same postdoc student that did the baseline examination. The postdoc student has not been in contact with any participant during the intervention period.
|
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 |
| Lørenskog |
| Akershus |
| 1478 |
| Norway |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |