Status:
COMPLETED
The Effect of Orofacial Myofunctional Therapy With Autofeedback on Obstructive Sleep Apnea
Lead Sponsor:
University Hospital, Akershus
Collaborating Sponsors:
University of Oslo
Oslo Metropolitan University
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
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 ana...
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 acce...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2025
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06079073
Start Date
August 29 2023
End Date
March 29 2025
Last Update
April 1 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Fertilitas clinic
Tallinn, Estonia, 10114
2
Akershus University Hospital
Lørenskog, Akershus, Norway, 1478