The Effect of Orofacial Myofunctional Therapy With Autofeedback on Obstructive Sleep Apnea
- Conditions
- Sleep Apnea, Obstructive
- Interventions
- Behavioral: Orofacial myofunctional therapy with autofeedback
- Registration Number
- NCT06079073
- Lead Sponsor
- University Hospital, Akershus
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
-
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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Application plus treatment module Orofacial myofunctional therapy with autofeedback 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
- Primary Outcome Measures
Name Time Method Apnea hypopnea index reduction 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.
- Secondary Outcome Measures
Name Time Method Change in desaturation severity parameter measured by medical device 3 months Measured by photoplethysmography obtained by self-applied somnography. More severity represents more disease.
Change in desaturation duration measured by medical device 3 months Measured by photoplethysmography obtained by self-applied somnography. Longer duration represents more disease.
Change in the Epworth Sleepines scale 3 months The scale is a validated tool measuring sleepiness between 0-24. Higher values represent more sleepiness
Orofacial myofunctional therapy adherence 3 months Measured by application registration between 1-3 per day. Three exercises per day is the maximum score
Change in objective sleep quality 3 months Measured by self-applied somnography. Sleep quality is the ratio between total sleep time and time in bed. A higher ratio is better.
Change in desaturation duration measured by wearable 3 months Measured by photoplethytsmography obtained by Withings Scan Watch. Longer duration represents more disease.
Change in stroop test 3 months Measured by Flexibility game in application. More correct answers is better
Changes in tongue strength 3 months Objective strength measured by the Iowa Oral Pressure Inventory. A higher score represents more strenght.
Change in reaction test 3 months Measured by reaction game in application. Shorter reaction time is better
Changes in tongue endurance 3 months Objective endurance measured by the Iowa Oral Pressure Inventory. A higher score represents more endurance.
Change in memory test 3 months Measured by memory game in application. Longer sequences memorized is better
Change general health status 3 months 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.
Changes in the Orofacial Myofunctional Evaluation with Scores 3 months Measured by scorer blinded for randomization. Range 37-103. A lower score represents more dysfunction.
Change in desaturation severity parameter measured by wearable 3 months Measured by photoplethytsmography obtained by Withings Scan Watch. More severity represents more disease.
Change in perception test 3 months Measured by perception game in application. More correct answers is better.
Trial Locations
- Locations (2)
Fertilitas clinic
🇪🇪Tallinn, Estonia
Akershus University Hospital
🇳🇴Lørenskog, Akershus, Norway