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

Last updated: March 29, 2025
Sponsor: University Hospital, Akershus
Overall Status: Completed

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

Orofacial myofunctional therapy with autofeedback

Clinical Study ID

NCT06079073
22/11571
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients referred to Ahus or the Fertilitas clinic

  • A diagnosis of obstructive sleep apnea according to the current InternationalClasssification of Sleep Disorders (ICSD) version 3 criteria {Berry, 2020, TheAASM Manual for the Scoring of Sleep and Associated Events: Rules', Terminologyand Technical Specifications', Version 2.6.;, 2014, Internationalclassification 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 thewritten 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

Exclusion Criteria:

  • Failure to fill in at least 70% of days in the electronic sleep diary provided inthe mobile app for two weeks.

  • Medical or psychiatric conditions which may interfere with the study protocolin the opinion of the investigator. Examples are acute psychosis, drug abuseand dementia. This will be noted in the study inclusion-exclusion document foreach approached candidate for the study. The information will then be discussedin an exlusion committee consisting of dr. Skirbekk, Jagomägi, Dammen andHrubos-Strøm.

  • Tongue-tie as described below. Participants with mouth opening of <50% with thetip of the tongue at the incisive papilla compared to total mouth opening willbe excluded.

Study Design

Total Participants: 106
Treatment Group(s): 1
Primary Treatment: Orofacial myofunctional therapy with autofeedback
Phase:
Study Start date:
August 29, 2023
Estimated Completion Date:
March 29, 2025

Study 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.

Connect with a study center

  • Fertilitas clinic

    Tallinn, 10114
    Estonia

    Site Not Available

  • Akershus University Hospital

    Lørenskog, Akershus 1478
    Norway

    Site Not Available

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