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

University Hospital, Akershus

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Behavioral: Orofacial myofunctional therapy with autofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT06079073

22/11571

Details and patient eligibility

About

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

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Application plus treatment module

Experimental group

Description:

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

Treatment:

Behavioral: Orofacial myofunctional therapy with autofeedback

Application awaiting access to treatment module

No Intervention group

Description:

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.