Phase
Condition
Sleep Apnea Syndromes
Treatment
Orofacial myofunctional therapy with autofeedback
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Fertilitas clinic
Tallinn, 10114
EstoniaSite Not Available
Akershus University Hospital
Lørenskog, Akershus 1478
NorwaySite Not Available
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