Back to resultsThe Effect of Orofacial Myofunctional Therapy With Autofeedback on Obstructive Sleep Apnea (OMTAOSA)
Primary Purpose
Sleep Apnea, Obstructive
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Orofacial myofunctional therapy with autofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive
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.
Sites / Locations
- Fertilitas clinicRecruiting
- Akershus University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Application plus treatment module
Application awaiting access to treatment module
Arm Description
The following exercises are pre-recorded and presented in the treatment module: Tongue Tongue brushing Tongue sliding Tongue suction Tongue down Soft palate 1. Elevate soft palate and uvula 2. Balloon blow Facial Put your finger in the oral cavity against your cheek. Pull against your finger with the cheek muscles. Air pump Exercise adherence is registered in a study application
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in the Epworth Sleepines scale
The scale is a validated tool measuring sleepiness between 0-24. Higher values represent more sleepiness
Orofacial myofunctional therapy adherence
Measured by application registration between 1-3 per day. Three exercises per day is the maximum score
Change in desaturation severity parameter measured by medical device
Measured by photoplethysmography obtained by self-applied somnography. More severity represents more disease.
Change in desaturation duration measured by medical device
Measured by photoplethysmography obtained by self-applied somnography. Longer duration represents more disease.
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.
Change in desaturation severity parameter measured by wearable
Measured by photoplethytsmography obtained by Withings Scan Watch. More severity represents more disease.
Change in desaturation duration measured by wearable
Measured by photoplethytsmography obtained by Withings Scan Watch. Longer duration represents more disease.
Change in stroop test
Measured by Flexibility game in application. More correct answers is better
Change in reaction test
Measured by reaction game in application. Shorter reaction time is better
Change in memory test
Measured by memory game in application. Longer sequences memorized is better
Change in perception test
Measured by perception game in application. More correct answers is better.
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.
Changes in the Orofacial Myofunctional Evaluation with Scores
Measured by scorer blinded for randomization. Range 37-103. A lower score represents more dysfunction.
Changes in tongue strength
Objective strength measured by the Iowa Oral Pressure Inventory. A higher score represents more strenght.
Changes in tongue endurance
Objective endurance measured by the Iowa Oral Pressure Inventory. A higher score represents more endurance.
Full Information
NCT ID
NCT06079073
First Posted
August 23, 2023
Last Updated
October 11, 2023
Sponsor
University Hospital, Akershus
Collaborators
University of Oslo, Oslo Metropolitan University, University of Tartu, Reykjavik University
1. Study Identification
Unique Protocol Identification Number
NCT06079073
Brief Title
The Effect of Orofacial Myofunctional Therapy With Autofeedback on Obstructive Sleep Apnea
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
University of Oslo, Oslo Metropolitan University, University of Tartu, Reykjavik University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Application plus treatment module
Arm Type
Experimental
Arm Description
The following exercises are pre-recorded and presented in the treatment module:
Tongue
Tongue brushing
Tongue sliding
Tongue suction
Tongue down Soft palate
1. Elevate soft palate and uvula 2. Balloon blow Facial
Put your finger in the oral cavity against your cheek. Pull against your finger with the cheek muscles.
Air pump Exercise adherence is registered in a study application
Arm Title
Application awaiting access to treatment module
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Orofacial myofunctional therapy with autofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Apnea hypopnea index reduction
Description
Measured by self-applied somnography. The index represents number of apneas or hypopneas per hour from 0/h. Higher values represents more severe disease.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in the Epworth Sleepines scale
Description
The scale is a validated tool measuring sleepiness between 0-24. Higher values represent more sleepiness
Time Frame
3 months
Title
Orofacial myofunctional therapy adherence
Description
Measured by application registration between 1-3 per day. Three exercises per day is the maximum score
Time Frame
3 months
Title
Change in desaturation severity parameter measured by medical device
Description
Measured by photoplethysmography obtained by self-applied somnography. More severity represents more disease.
Time Frame
3 months
Title
Change in desaturation duration measured by medical device
Description
Measured by photoplethysmography obtained by self-applied somnography. Longer duration represents more disease.
Time Frame
3 months
Title
Change in objective sleep quality
Description
Measured by self-applied somnography. Sleep quality is the ratio between total sleep time and time in bed. A higher ratio is better.
Time Frame
3 months
Title
Change in desaturation severity parameter measured by wearable
Description
Measured by photoplethytsmography obtained by Withings Scan Watch. More severity represents more disease.
Time Frame
3 months
Title
Change in desaturation duration measured by wearable
Description
Measured by photoplethytsmography obtained by Withings Scan Watch. Longer duration represents more disease.
Time Frame
3 months
Title
Change in stroop test
Description
Measured by Flexibility game in application. More correct answers is better
Time Frame
3 months
Title
Change in reaction test
Description
Measured by reaction game in application. Shorter reaction time is better
Time Frame
3 months
Title
Change in memory test
Description
Measured by memory game in application. Longer sequences memorized is better
Time Frame
3 months
Title
Change in perception test
Description
Measured by perception game in application. More correct answers is better.
Time Frame
3 months
Title
Change general health status
Description
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.
Time Frame
3 months
Title
Changes in the Orofacial Myofunctional Evaluation with Scores
Description
Measured by scorer blinded for randomization. Range 37-103. A lower score represents more dysfunction.
Time Frame
3 months
Title
Changes in tongue strength
Description
Objective strength measured by the Iowa Oral Pressure Inventory. A higher score represents more strenght.
Time Frame
3 months
Title
Changes in tongue endurance
Description
Objective endurance measured by the Iowa Oral Pressure Inventory. A higher score represents more endurance.
Time Frame
3 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Category "non-binary" possible
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harald Hrubos-Strøm, PhD
Phone
+47 67964015
Email
hrsr@ahus.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald Hrubos-Strøm, PhD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertilitas clinic
City
Tallinn
ZIP/Postal Code
10114
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Triin Jagomägi, Orthodontist
Phone
25153634
Ext
+37
Email
triin.jagomagi@ut.ee
First Name & Middle Initial & Last Name & Degree
Heisl Vaher, MD
Email
heislvaher@gmail.com
Facility Name
Akershus University Hospital
City
Lørenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harald Hrubos-Strøm, PhD
Phone
97522112
Ext
+47
Email
hrsr@ahus.no
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not allowed by Regional Ethical Committee
Learn more about this trial
The Effect of Orofacial Myofunctional Therapy With Autofeedback on Obstructive Sleep Apnea
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