Skip to main content
OpenTrials
Completed

NCT Number: NCT06079073

The Effect of Orofacial Myofunctional Therapy With Autofeedback on 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fertilitas clinic, Tallinn, Estonia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in the Epworth Sleepines scale

    Time frame: 3 months

    The scale is a validated tool measuring sleepiness between 0-24. Higher values represent more sleepiness

  2. Orofacial myofunctional therapy adherence

    Time frame: 3 months

    Measured by application registration between 1-3 per day. Three exercises per day is the maximum score

  3. Change in desaturation severity parameter measured by medical device

    Time frame: 3 months

    Measured by photoplethysmography obtained by self-applied somnography. More severity represents more disease.

  4. Change in desaturation duration measured by medical device

    Time frame: 3 months

    Measured by photoplethysmography obtained by self-applied somnography. Longer duration represents more disease.

  5. Change in objective sleep quality

    Time frame: 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.

  6. Change in desaturation severity parameter measured by wearable

    Time frame: 3 months

    Measured by photoplethytsmography obtained by Withings Scan Watch. More severity represents more disease.

  7. Change in desaturation duration measured by wearable

    Time frame: 3 months

    Measured by photoplethytsmography obtained by Withings Scan Watch. Longer duration represents more disease.

  8. Change in stroop test

    Time frame: 3 months

    Measured by Flexibility game in application. More correct answers is better

  9. Change in reaction test

    Time frame: 3 months

    Measured by reaction game in application. Shorter reaction time is better

  10. Change in memory test

    Time frame: 3 months

    Measured by memory game in application. Longer sequences memorized is better

  11. Change in perception test

    Time frame: 3 months

    Measured by perception game in application. More correct answers is better.

  12. Change general health status

    Time frame: 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.

  13. Changes in the Orofacial Myofunctional Evaluation with Scores

    Time frame: 3 months

    Measured by scorer blinded for randomization. Range 37-103. A lower score represents more dysfunction.

  14. Changes in tongue strength

    Time frame: 3 months

    Objective strength measured by the Iowa Oral Pressure Inventory. A higher score represents more strenght.

  15. Changes in tongue endurance

    Time frame: 3 months

    Objective endurance measured by the Iowa Oral Pressure Inventory. A higher score represents more endurance.

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • Oslo Metropolitan University
  • Reykjavik University
  • University of Oslo
  • University of Tartu

Registry information

Official study 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

Acronym: OMTAOSA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 12, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.