The Effect of Orofacial Myofunctional Therapy With Autofeedback on Obstructive Sleep Apnea (NCT06079073) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Orofacial Myofunctional Therapy With Autofeedback on Obstructive Sleep Apnea
Estonia, Norway106 participantsStarted 2023-08-29
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* T…