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

NCT06079073 | Completed

• 1 other identifier: 22/11571
• Study Type: interventional
• Target: 106
• Locations: 2 countries
• Sites: 2

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 anatomical and behavioural predictors of OMT adherence

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Change in the Epworth Sleepines scale

  3 months

• Orofacial myofunctional therapy adherence

  3 months

• Change in desaturation severity parameter measured by medical device

  3 months

• Change in desaturation duration measured by medical device

  3 months

• Change in objective sleep quality

  3 months

Study Arms (2)

Application plus treatment module

EXPERIMENTAL

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

Behavioral: Orofacial myofunctional therapy with autofeedback

Application awaiting access to treatment module

NO INTERVENTION

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.

Interventions

Orofacial myofunctional therapy with autofeedback BEHAVIORAL

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.

Application plus treatment module

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Category "non-binary" possible
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Failure to fill in at least 70% of days in the electronic sleep diary provided in the mobile app for two weeks.
• 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.

Sponsors & Collaborators

• University Hospital, Akershus: lead
• University of Oslo: collaborator
• Oslo Metropolitan University: collaborator
• University of Tartu: collaborator
• Reykjavik University: collaborator

Study Sites (2)

Fertilitas clinic

Tallinn, 10114, Estonia

Location

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Location

Related Publications (1)

• Koster A, Hoang AD, Dashuk A, Vaher H, Sikk K, Jagomagi T. Effects of Web-Based Orofacial Myofunctional Therapy on Hyoid Bone Position in Adults with Mild to Moderate Obstructive Sleep Apnea: Evidence from an Estonian Substudy of a Randomized Controlled Trial. J Clin Med. 2025 Dec 29;15(1):257. doi: 10.3390/jcm15010257.

  PMID: 41517505 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Harald Hrubos-Strøm, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization is conducted at the end of the baseline assessment. Participants in the intervention group is handled by an OMT therapist until outcome assessment by the same postdoc student that did the baseline examination. The postdoc student has not been in contact with any participant during the intervention period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, senior consultant and head of research group, principal investigator

Model Details: Block randomization to ensure 40% female participants. Intervention: Access to treatment module in application plus access to OMT therapist. Control: Access to application without treatment module. No scheduled appointments with OMT therapist.

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: October 12, 2023
• Study Start: August 29, 2023
• Primary Completion: March 29, 2025
• Study Completion: March 29, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); NO (1)