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

University Hospital, Akershus2 sites in 2 countries106 target enrollmentAugust 29, 2023

ConditionsSleep Apnea, Obstructive

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sleep Apnea, Obstructive
Sponsor: University Hospital, Akershus
Enrollment: 106
Locations: 2
Primary Endpoint: Apnea hypopnea index reduction
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 29, 2023

End Date

March 29, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Akershus

Responsible Party

Principal Investigator

Harald Hrubos-Strøm

MD, PhD, senior consultant and head of research group, principal investigator

University Hospital, Akershus

Eligibility Criteria

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) \<
•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.

Outcomes

Primary Outcomes

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.