The Effect of Orofacial Myofunctional Therapy With Autofeedback on Obstructive Sleep Apnea (OMTAOSA)

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

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Behavioral: Orofacial myofunctional therapy with autofeedback

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Estonia
  • Tallinn, Estonia, 10114
    • Fertilitas clinic
• Norway
  • Akershus
    • Lørenskog, Akershus, Norway, 1478
      • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Application plus treatment module; The following exercises are pre-recorded and presented in the treatment module: Tongue; Tongue brushing; Tongue sliding; Tongue suction; Tongue down Soft palate 1. Elevate soft palate and uvula 2. Balloon blow Facial; Put your finger in the oral cavity against your cheek. Pull against your finger with the cheek muscles.; Air pump Exercise adherence is registered in a study application	Behavioral: Orofacial myofunctional therapy with autofeedback; 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.
No Intervention: Application awaiting access to treatment module; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: University of Oslo; University of Tartu; Reykjavik University; Oslo Metropolitan University
• Investigators: Principal Investigator: Harald Hrubos-Strøm, PhD, University Hospital, Akershus

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2023
• Primary Completion (Actual): March 29, 2025
• Study Completion (Actual): March 29, 2025

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 22/11571

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not allowed by Regional Ethical Committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No