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Trial registered on ANZCTR


Registration number
ACTRN12623000269639
Ethics application status
Approved
Date submitted
17/01/2023
Date registered
13/03/2023
Date last updated
3/11/2024
Date data sharing statement initially provided
13/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel myofunctional device therapy for patients with mild to moderate sleep apnoea.
Scientific title
Investigation of the Efficacy of Myosa S1 and S1®Hybrid Appliance in treating Mild to Moderate Obstructive Sleep Apnoea: A Pilot Study
Secondary ID [1] 308540 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 328384 0
Condition category
Condition code
Respiratory 325413 325413 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will employ the use of two devices: the Myosa S1 and Myosa S1®Hybrid (S1H) device.
The S1 device is typically used to progressively rehabilitate patients with TMJ and airway disorders. It has appliance features which passively position the patients jaw and muscles into an ideal position to decompress the TMJ and open the airway. The device consists of 4 breathing holes which regulate oral breathing, a tongue elevator and tongue tag which lift the tongue into correct position out of airway, a lip bumper to retrain the atypical swallow, and an edge to edge offset and thick base to open the airway.
The S1H is a similar device to the S1 but with additional 'active' features (i.e. includes tongue, lip and jaw press tubes) which allow the patient to press on, and actively exercise tongue lip and jaw muscles respectively. An exercise program is used along with the S1H to fatigue the oral and airway muscles while bringing awareness to nasal breathing.

Over a total of 14 weeks use of the Myosa S1 and Myosa S1®Hybrid (S1H) devices in two phases:
Phase 1: Weeks 1 & 2 will involve wearing the S1 appliance for 1-2 hours while awake and overnight while asleep.
Phase 2: Week 3-14 will repeat the appliance prescription for Phase I (i.e. Participants will continue to use the S1 appliance overnight and 1-2 hours per day), in addition to the use of prescribed active muscle exercising. The muscle training will be accomplished by using the active S1H appliance features for 10min twice a day.
Following an initial baseline polysomnography (PSG), participants will commence Phase 1, after which a follow-up PSG will be repeated at the end of Phase 1. After Phase 1 is complete, Phase 2 will commence and conclude at the end of week 14 with a final PSG.

Description of the active muscle exercising to be performed during each week of Phase 2 of the trial with the S1H:
Weeks 3-6:
Lips - Press and release x 3 then press and hold closed for 3 light slow gentle nasal breaths.
Tongue - Press and release x 3 times then press and hold for 3 breaths.
Jaw - Press and release x 3 then press and hold jaw and lip tube for 3 nasal breaths.
Repeat series 2 times.

Weeks 7-10:
Lips - Press and release x 5 then press and hold closed for 5 light slow gentle nasal breaths.
Tongue - Press and release x 5 times then press and hold for 5 breaths.
Jaw - Press and release x 5 then press and hold jaw and lip tube for 5 nasal breaths.
Repeat series 2 times.

Weeks 11-14:
Lips - Add head tilt and press and release x 5 then press and hold closed for 5 light slow gentle nasal breaths.
Tongue - Add head tilt and press and release x 5 times then press and hold for 5 breaths.
Jaw - Add head tilt and jaw press and release x 5 then press and hold jaw and lip tube for 5 nasal breaths.
Repeat series 2 times.

Participants will be asked to complete a daily logbook to monitor adherence to the program.
Intervention code [1] 324986 0
Treatment: Devices
Comparator / control treatment
No Control Group. Each individual will be compared to themselves.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333274 0
Apnoea-Hypopnoea Index (AHI)
Timepoint [1] 333274 0
Assessed via polysomnography at:
1, Day 1 (Baseline)
2. End of week 2 and
3. End of week 14
Secondary outcome [1] 416427 0
Arousal index
Timepoint [1] 416427 0
Assessed via polysomnography at:
1, Day 1 (Baseline)
2. End of week 2 and
3. End of week 14
Secondary outcome [2] 416428 0
Oxygen Desaturation Index
Timepoint [2] 416428 0
Assessed via polysomnography at:
1, Day 1 (Baseline)
2. End of week 2 and
3. End of week 14
Secondary outcome [3] 416429 0
Hypoxic burden
Timepoint [3] 416429 0
Assessed via polysomnography at:
1, Day 1 (Baseline)
2. End of week 2 and
3. End of week 14

Eligibility
Key inclusion criteria
Otherwise healthy patients with obstructive sleep apnoea, as diagnosed
by an AHI between 5 and 50 events/hr inclusive.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Obesity (BMI > 32 kg/m2)
• Sleep disorder other than OSA, including narcolepsy
• ESS >15 (out of 24 points at Screening)
• Clinically significant craniofacial malformation
• Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or uncontrolled hypertension
• Clinically significant neurological disorder (including epilepsy/convulsions)
• Clinically significant cognitive dysfunction
• Participants who have had upper airway surgery < 1 year before the trial
• Respiratory disorders (including asthma)
• Participants with central sleep apnea (central apnea index >10 /hr and more than 50% of respiratory events classed as central)
• Participants undergoing concomitant treatment for snoring/OSA or who have discontinued CPAP < 1 week before the trial
• Participants with severe sleep apnea (AHI >30)
• Participants with OSA associated with a syndrome or genetic disorder
• Participants with uncontrolled diabetes
• Participants with diagnosed active depression/anxiety (self-report on the HADS)
• Participants with allergies to the appliance material
• Women who are pregnant or breastfeeding
• Participants with full or partial dentures
• Participants with acute TMJ issues
• Participants with active periodontal disease, teeth, or other jaw disorders which may be impacted by an intraoral appliances
• Typical sleep duration < 4 hours
• Motor vehicle accident or near-miss motor vehicle accident in the past 2 years related to sleepiness, tiredness or fatigue
• Participants on medications that will substantially affect respiration, including (but not limited to) opioids, barbiturates, theophylline, doxapram, acetazolamide, pseudoephedrine
• Unwilling to limit caffeinated beverage intake (e.g., coffee, cola, tea) to 400 mg/day or less of caffeine (approximately 4 cups of coffee); caffeine not to be used within 3 hours of bedtime
• Any condition that in the investigator’s opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation
• Participant considered by the investigator, for any reason, an unsuitable candidate to use the oral appliance, or unable or unlikely to understand or comply with the study instructions or study evaluations

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed-effect modelling will be used to assess the effect of the the device on the primary and secondary outcomes. This analysis will use treatment condition [baseline, Phase 1, Phase 2] as a fixed effect and Participant as a random effect. Data will be analysed on a per protocol basis, but a supplementary intention to treat analysis will be conducted and the results of the two analyses will be compared.

Data from the baseline polysomnogram (PSG) will provide baseline pathophysiological information for each patient. Multiple linear regression will be conducted to determine which baseline clinical and physiological variables are independently related to the greatest therapeutic reduction OSA severity (measured by apnoea-hypopnoea index, AHI).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
31/03/2023
Actual
30/08/2023
Date of last participant enrolment
Anticipated
31/12/2023
Actual
19/08/2024
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312788 0
Commercial sector/Industry
Name [1] 312788 0
Myofunctional Research Company
Country [1] 312788 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 314421 0
None
Name [1] 314421 0
Address [1] 314421 0
Country [1] 314421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312077 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 312077 0
Ethics committee country [1] 312077 0
Australia
Date submitted for ethics approval [1] 312077 0
31/08/2022
Approval date [1] 312077 0
14/11/2022
Ethics approval number [1] 312077 0
32393

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123386 0
A/Prof Bradley Edwards
Address 123386 0
Sleep and Circadian Medicine Laboratory Department of Physiology, School of Psychological Sciences and Turner Institute for Brain and Mental Health
Faculty of Medicine, Nursing and Health Sciences Monash University
264 Ferntree Gully Road
Notting Hill, VIC 3168, Australia
Country 123386 0
Australia
Phone 123386 0
+613 9905 0187
Fax 123386 0
Email 123386 0
bradley.edwards@monash.edu
Contact person for public queries
Name 123387 0
Jinny Collet
Address 123387 0
Sleep and Circadian Medicine Laboratory Department of Physiology, School of Psychological Sciences and Turner Institute for Brain and Mental Health
Faculty of Medicine, Nursing and Health Sciences Monash University
264 Ferntree Gully Road
Notting Hill, VIC 3168, Australia
Country 123387 0
Australia
Phone 123387 0
+61 3 9905 9587
Fax 123387 0
Email 123387 0
jinny.collet@monash.edu
Contact person for scientific queries
Name 123388 0
Bradley Edwards
Address 123388 0
Sleep and Circadian Medicine Laboratory Department of Physiology, School of Psychological Sciences and Turner Institute for Brain and Mental Health
Faculty of Medicine, Nursing and Health Sciences Monash University
264 Ferntree Gully Road
Notting Hill, VIC 3168, Australia
Country 123388 0
Australia
Phone 123388 0
+613 9905 0187
Fax 123388 0
Email 123388 0
bradley.edwards@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The company sponsoring the trial wants to keep the individual data confidential for internal commercial reasons.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.