Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000966493
Ethics application status
Approved
Date submitted
18/08/2025
Date registered
3/09/2025
Date last updated
3/09/2025
Date data sharing statement initially provided
3/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the efficacy and tolerability of CPAP administered through a novel interface
Scientific title
Investigating the efficacy and tolerability of CPAP administered through the S1H oral device: a pilot study
Secondary ID [1] 315159 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea 338590 0
Condition category
Condition code
Respiratory 334889 334889 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are conducting a trial of a novel device (S1H oral device) modified for the delivery of continuous positive airway pressure (CPAP) in individuals with obstructive sleep apnea (OSA). The S1H device is typically used to progressively rehabilitate patients with temporomandibular joint (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 device also includes tongue, lip and jaw press tubes which allow the patient to press on and actively exercise tongue lip and jaw muscles respectively. In the current study, the device will be placed in the participants mouth (like a mouthguard) and CPAP will be delivered through the oral port.

Briefly participants will undergo two assessments. Part A will involve an in laboratory assessment and if completed successfully, participants will invited into an at home trial.

Part A: In-lab assessment
In a randomised order, participants will be fitted with either their own CPAP mask (Usual mask interface) or the modified S1H oral device. The mask will be briefly tested under pressure and adjusted to find an optimal comfort/mask seal settings. Once fitted, participants will lie on the bed and wear the interface while CPAP is applied for a minimum of 30 mins. The CPAP machine will be set to start pressure at 4cmH2O and will ramp to the patients current prescribed CPAP level (or 90/95th%tile equivalent setting) over 5 minutes. After ramping, participants will remain lying in bed for a further 20 minutes at their prescribed CPAP level.

During this period, participants will be asked to complete subjective assessments of comfort/tolerability (Landry intolerability scale) every 5 minutes. Ventilation and mask leak will also be continuously recorded through this session. At the completion of this session participants will also be asked “Compared to their own mask do you find the tolerability of this interface to be more, less or the same as your current mask.”

This laboratory test will provide detailed data regarding the performance and tolerability of the S1H oral device, but will also serve as an important acclimatization period that will allow us to test whether participants will be able to tolerate the mask sufficiently to proceed further to overnight use of the device during sleep.

Part B: At-home performance.
Subjects will next participate in a randomized non-blinded cross-over trial. Participants will be randomized to use either the (1) Usual mask interface or (2) S1H oral device with CPAP connection first.

Patients will be given a CPAP machine (Phillips Dreamstation) and will use this machine with the interface they are randomised to for 2 weeks in the home. Participants will be encouraged to use the interface for the entire sleep period every night (i.e. as long as they can tolerate). At the end of this two weeks, the investigators will download the machines data (either in person or via the cloud). Participants will also be asked to fill out questionnaires that capture symptoms (ESS) and side effects of the interface used (i.e. TMJ issues, discomfort, mouth ulcers, comfort, ease of cleaning, dry mouth etc).

Participants will then cross over to the other interface and use that for a period of two weeks. In the second arm, Participants will fill out the same questionnaires. At the conclusion of the study, patients will be asked which interface they prefer and why.
Intervention code [1] 331778 0
Treatment: Devices
Comparator / control treatment
Usual CPAP interface
Control group
Active

Outcomes
Primary outcome [1] 342513 0
Part A: Landry Tolerability Scale Score
Timepoint [1] 342513 0
End of Part A (1 day in-lab assessment)
Primary outcome [2] 342514 0
Part B: CPAP pressure requirement
Timepoint [2] 342514 0
End of each 2-week trial of CPAP interface
Secondary outcome [1] 451127 0
Part A: Mask Leak
Timepoint [1] 451127 0
During the in-lab acclimatization period
Secondary outcome [2] 451129 0
Part A: Respiratory Ventilation
Timepoint [2] 451129 0
During the in-lab acclimatization period
Secondary outcome [3] 451130 0
Part B: Nightly CPAP use
Timepoint [3] 451130 0
End of each 2-week trial of CPAP interface
Secondary outcome [4] 451131 0
Part B: Residual OSA severity
Timepoint [4] 451131 0
End of each 2-week trial of CPAP interface
Secondary outcome [5] 451132 0
Part B: Leak
Timepoint [5] 451132 0
End of each 2-week trial of CPAP interface
Secondary outcome [6] 451133 0
Part B: Average quality of sleep VAS score
Timepoint [6] 451133 0
Daily sleep diary for up to two weeks
Secondary outcome [7] 451134 0
Part B: Average comfort of mask interface VAS score
Timepoint [7] 451134 0
Daily sleep diary for up to two weeks

Eligibility
Key inclusion criteria
1. Age 18 years and older
2. Diagnosed with OSA and is currently using CPAP
3. Willingness to complete study procedures
4. Ability to speak fluent English and provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any untreated/uncontrolled medical conditions
2. Major craniofacial or abnormal upper airway anatomy
3. Current use medications that could affect ventilation or expired CO2 (opioids, carbonic anhydrase inhibitors, etc.)
4. Currently or possibly pregnant or lactating
5. People with allergies to appliance material
6. People with full or partial dentures
7. People with TMJ abnormalities or any jaw symptoms (including clicking, locking, crepitus and discomfort)
8. People with active periodontal disease, teeth or other jaw disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models comparing mask type (current CPAP interface vs modified S1H oral device interface) as a fixed effect and participant will be modelled as a random intercept.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319736 0
Commercial sector/Industry
Name [1] 319736 0
Myofunctional Research Company
Country [1] 319736 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 322239 0
None
Name [1] 322239 0
Address [1] 322239 0
Country [1] 322239 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318286 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 318286 0
Ethics committee country [1] 318286 0
Australia
Date submitted for ethics approval [1] 318286 0
27/02/2025
Approval date [1] 318286 0
08/05/2025
Ethics approval number [1] 318286 0
45856

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

Contacts
Principal investigator
Name 143706 0
A/Prof Bradley Edwards
Address 143706 0
Sleep and Circadian Medicine Laboratory, 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 143706 0
Australia
Phone 143706 0
+613 9905 0187
Fax 143706 0
Email 143706 0
[email protected]
Contact person for public queries
Name 143707 0
Trisha Emperado
Address 143707 0
Sleep and Circadian Medicine Laboratory, 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 143707 0
Australia
Phone 143707 0
+613 9905 9587
Fax 143707 0
Email 143707 0
[email protected]
Contact person for scientific queries
Name 143708 0
Bradley Edwards
Address 143708 0
Sleep and Circadian Medicine Laboratory, 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 143708 0
Australia
Phone 143708 0
+61 3 9905 0187
Fax 143708 0
Email 143708 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The company funding 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.