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Trial registered on ANZCTR


Registration number
ACTRN12621001301853
Ethics application status
Approved
Date submitted
13/08/2021
Date registered
27/09/2021
Date last updated
23/06/2024
Date data sharing statement initially provided
27/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Conventional vs custom made nasal Continuous Positive Airway Pressure (CPAP) mask for treatment of Obstructive Sleep Apnoea: Pilot study A
Scientific title
Conventional vs custom made nasal Continuous Positive Airway Pressure (CPAP) mask for treatment of Obstructive Sleep Apnoea in adults: Pilot study A
Secondary ID [1] 304429 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea (OSA) 323029 0
Condition category
Condition code
Respiratory 320595 320595 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Maximum total duration of the study is 7 weeks, from enrollment to conclusion of the third visit.

Duration of the first visit is 15 minutes. An eligible participant, who owns and is currently using their CPAP machine with conventional nasal CPAP mask (any commercial brand), will have their face scanned by a purpose-built portable 3D scanner. The scan takes 60 seconds, and is performed once. The scanned information is then instantly transferred to a secured server that can only be accessed by the study coordinator and a qualified engineer of the 3D scanner's company. The information is used for 3D printing of a custom made nasal CPAP mask. The mask is printed by the engineer using the company's purpose-built high-tech 3D printing. The printing process takes approximately 2 weeks. The study coordinator has been trained to operate the scanner and to fit the mask by the company’s engineer prior to the study's recruitment.

Duration of the second visit is 30 minutes. The visit takes place when the custom made nasal CPAP mask is ready for fitting. During this visit, the participant will have CPAP usage data during the 4 weeks prior to this second visit downloaded from the machine SIM card by the study coordinator using a commercially available software for CPAP data capture and analysis. Patient has been using their own CPAP machine prior to enrollment. The CPAP machine records its usage as part of its functionalities/clinical routine. Therefore, the 4 weeks of CPAP usage data is approximately 2 weeks prior to enrollment plus 2 weeks from the first visit to the second visit (while the custom made mask is being made). No training is required as the study coordinator is already experienced in using the software. The participant will be fitted with their custom made nasal CPAP mask by the study coordinator. He/She will be educated on the use of the CPAP mask, including how to properly wear the mask, and proper cleaning technique by verbal instruction only from the study coordinator. There is no minimum or maximum time limit for nightly use of the custom made nasal CPAP mask, and the usage will not be monitored.

Duration of the third visit is 15 minutes. This visit takes place 4 weeks after the second visit. During this visit, the participant will have CPAP usage data during the 4 weeks since the second visit downloaded from the machine SIM card by the study coordinator.

A custom made nasal CPAP mask will be provided to all participants in the study at no cost. Participants will be permitted to retain their custom made nasal CPAP masks free of charge at the conclusion of the study if deemed clinically useful by their treating sleep physicians.
Intervention code [1] 321294 0
Treatment: Devices
Comparator / control treatment
Conventional nasal CPAP mask usage data of participants during the 4 weeks prior to the second visit (for a custom made nasal CPAP mask fitting) will be used for comparison.
Control group
Historical

Outcomes
Primary outcome [1] 328609 0
Adherence to CPAP treatment measured by the percentage of nights with at least 4 hours usage from the analysis of the downloaded CPAP usage data.
Timepoint [1] 328609 0
At the end of 4 weeks post-treatment commencement (i.e., after custom made mask fitting).
Secondary outcome [1] 399632 0
Amount of mask leak assessed by the average of leaking time per night from the analysis of the downloaded CPAP usage data.
Timepoint [1] 399632 0
At the end of 4 weeks post-treatment commencement (i.e., after custom made mask fitting).
Secondary outcome [2] 399633 0
OSA control assessed by the average Apnea Hypopnea Index (AHI) from the analysis of the downloaded CPAP usage data.
Timepoint [2] 399633 0
At the end of 4 weeks post-treatment commencement (i.e., after custom made mask fitting).
Secondary outcome [3] 399634 0
Self-assessment perceived comfort assessed by a questionnaire designed specifically for this study.
Timepoint [3] 399634 0
At the end of 4 weeks post-treatment commencement (i.e., after custom made mask fitting).

Eligibility
Key inclusion criteria
1. Diagnosis of OSA, defined as an AHI of more than 5 events per hour.
2. Recommended for CPAP therapy by a sleep physician.
3. Trialed CPAP therapy, with suboptimal tolerance and compliance (less than 70% of nights with at least 4 hours usage) over a period of at least 4 weeks.
4. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
5. Proficiency in English language.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant nasal resistance (i.e., unable to breathe through with the mouth closed).
2. Prior upper airway surgery for OSA.
3. Unstable psychiatric or psychological illness that would prevent accurate reporting.
4. Patient is unable to understand the research project.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/10/2021
Actual
6/05/2022
Date of last participant enrolment
Anticipated
31/01/2025
Actual
12/05/2023
Date of last data collection
Anticipated
28/03/2025
Actual
7/09/2023
Sample size
Target
40
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20240 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 34973 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 308793 0
Commercial sector/Industry
Name [1] 308793 0
Bespoke Medical Innovations Pty Ltd
Country [1] 308793 0
Australia
Primary sponsor type
Individual
Name
Prof Andrew Chan
Address
Level 8A Department of Respiratory and Sleep Medicine
Acute Services Building, Royal North Shore Hospital
Reserve Rd, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 309709 0
None
Name [1] 309709 0
Address [1] 309709 0
Country [1] 309709 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308705 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 308705 0
Ethics committee country [1] 308705 0
Australia
Date submitted for ethics approval [1] 308705 0
Approval date [1] 308705 0
28/04/2020
Ethics approval number [1] 308705 0
2020/ETH00691

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

Contacts
Principal investigator
Name 111626 0
Prof Andrew Chan
Address 111626 0
Level 8A Department of Respiratory and Sleep Medicine
Acute Services Building, Royal North Shore Hospital
Reserve Rd, St Leonards NSW 2065
Country 111626 0
Australia
Phone 111626 0
+61 2 9463 2933
Fax 111626 0
Email 111626 0
andrew.chan@sydney.edu.au
Contact person for public queries
Name 111627 0
Andrew Chan
Address 111627 0
Level 8A Department of Respiratory and Sleep Medicine
Acute Services Building, Royal North Shore Hospital
Reserve Rd, St Leonards NSW 2065
Country 111627 0
Australia
Phone 111627 0
+61 2 9463 2933
Fax 111627 0
Email 111627 0
andrew.chan@sydney.edu.au
Contact person for scientific queries
Name 111628 0
Andrew Chan
Address 111628 0
Level 8A Department of Respiratory and Sleep Medicine
Acute Services Building, Royal North Shore Hospital
Reserve Rd, St Leonards NSW 2065
Country 111628 0
Australia
Phone 111628 0
+61 2 9463 2933
Fax 111628 0
Email 111628 0
andrew.chan@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.