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

Sleep Apnea, Obstructive Clinical Trial

— OMTAOSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06079073
• Other study ID #: 22/11571
• Status: Recruiting
• Phase: N/A
• Start date: August 29, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: October 2023
• Source: University Hospital, Akershus
• Contact: Harald Hrubos-Strøm, PhD
• Phone: +47 67964015
• Email: hrsr[@]ahus.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Orofacial myofunctional therapy with autofeedback
Participants opening a code unlocking the OMTa treatment module of the application will be given a direct communication link to the PhD students, Diana Hansen (Norway) and Andres Koster (Estonia) and two research co-ordinators. Dr. Hansen and Andres Köster has obtained an Academy of Orofacial Myofunctional Therapy (AOMT) certification diploma. One physical start up session will be scheduled at Ahus and at North Estonia Medical Center. This 60 minute session will be used to instruct participants in OMT exercises and use of the app. All participants will receive a disposable toothbrush and standardized balloons. After that, biweekly video sessions (time 20-30 min) will be scheduled.

Locations

Country	Name	City	State
Estonia	Fertilitas clinic	Tallinn
Norway	Akershus University Hospital	Lørenskog	Akershus

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Akershus	Oslo Metropolitan University, Reykjavik University, University of Oslo, University of Tartu

Countries where clinical trial is conducted

Estonia,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea hypopnea index reduction	Measured by self-applied somnography. The index represents number of apneas or hypopneas per hour from 0/h. Higher values represents more severe disease.	3 months
Secondary	Change in the Epworth Sleepines scale	The scale is a validated tool measuring sleepiness between 0-24. Higher values represent more sleepiness	3 months
Secondary	Orofacial myofunctional therapy adherence	Measured by application registration between 1-3 per day. Three exercises per day is the maximum score	3 months
Secondary	Change in desaturation severity parameter measured by medical device	Measured by photoplethysmography obtained by self-applied somnography. More severity represents more disease.	3 months
Secondary	Change in desaturation duration measured by medical device	Measured by photoplethysmography obtained by self-applied somnography. Longer duration represents more disease.	3 months
Secondary	Change in objective sleep quality	Measured by self-applied somnography. Sleep quality is the ratio between total sleep time and time in bed. A higher ratio is better.	3 months
Secondary	Change in desaturation severity parameter measured by wearable	Measured by photoplethytsmography obtained by Withings Scan Watch. More severity represents more disease.	3 months
Secondary	Change in desaturation duration measured by wearable	Measured by photoplethytsmography obtained by Withings Scan Watch. Longer duration represents more disease.	3 months
Secondary	Change in stroop test	Measured by Flexibility game in application. More correct answers is better	3 months
Secondary	Change in reaction test	Measured by reaction game in application. Shorter reaction time is better	3 months
Secondary	Change in memory test	Measured by memory game in application. Longer sequences memorized is better	3 months
Secondary	Change in perception test	Measured by perception game in application. More correct answers is better.	3 months
Secondary	Change general health status	Measured by a visual analogue scale in the BEAMER questionnaire, two visio analogue scales on general health and 3 items on acceptance and control scored 1-6 respectively.	3 months
Secondary	Changes in the Orofacial Myofunctional Evaluation with Scores	Measured by scorer blinded for randomization. Range 37-103. A lower score represents more dysfunction.	3 months
Secondary	Changes in tongue strength	Objective strength measured by the Iowa Oral Pressure Inventory. A higher score represents more strenght.	3 months
Secondary	Changes in tongue endurance	Objective endurance measured by the Iowa Oral Pressure Inventory. A higher score represents more endurance.	3 months