Clinical trial NCT06079073: The Effect of Orofacial Myofunctional Therapy With Autofeedback on Obstructive Sleep Apnea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Oslo Metropolitan University
name: University of Tartu
name: Reykjavik University
First posted: 2023-10-12
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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 access to the treatment module after 3 monts of waiting. Outcomes will be assessed by a researcher blinded for the randomization result.

Eligibility criteria: 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.

Primary outcomes:
measure: Apnea hypopnea index reduction
timeFrame: 3 months
Secondary outcomes:
measure: Change in the Epworth Sleepines scale
timeFrame: 3 months
measure: Orofacial myofunctional therapy adherence
timeFrame: 3 months
measure: Change in desaturation severity parameter measured by medical device
timeFrame: 3 months
measure: Change in desaturation duration measured by medical device
timeFrame: 3 months
measure: Change in objective sleep quality
timeFrame: 3 months
measure: Change in desaturation severity parameter measured by wearable
timeFrame: 3 months
measure: Change in desaturation duration measured by wearable
timeFrame: 3 months
measure: Change in stroop test
timeFrame: 3 months
measure: Change in reaction test
timeFrame: 3 months
measure: Change in memory test
timeFrame: 3 months
measure: Change in perception test
timeFrame: 3 months
measure: Change general health status
timeFrame: 3 months
measure: Changes in the Orofacial Myofunctional Evaluation with Scores
timeFrame: 3 months
measure: Changes in tongue strength
timeFrame: 3 months
measure: Changes in tongue endurance
timeFrame: 3 months
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: Fertilitas clinic
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Akershus
Study officials:
affiliation: University Hospital, Akershus
name: Harald Hrubos-Strøm, PhD
role: PRINCIPAL_INVESTIGATOR
References: