Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001649202
Ethics application status
Approved
Date submitted
28/09/2018
Date registered
5/10/2018
Date last updated
23/09/2019
Date data sharing statement initially provided
23/09/2019
Date results information initially provided
23/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Using Acoustic Tools to Improve Patient Experience with CPAP therapy
Scientific title
Feasibility of Using Acoustic Tools for Improved Patient Experience with CPAP therapy
Secondary ID [1] 296194 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnoea 309833 0
Condition category
Condition code
Respiratory 308622 308622 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will use an approved loan CPAP device, with an external module to collect acoustic signals from the tube and mask, for 7 nights with their normal mask and therapy settings in the home environment. Standard therapy involves wearing a CPAP mask with pressure applied, as prescribed by a physician, for duration of sleep cycle to treat sleep apnoea. Participants will complete a short diary entry each morning documenting bedroom and sleep set-up.

The prototype external module contains microphones which are coupled to the air path and record the sound in the tube whilst therapy is on. It is attached to the CPAP device between the CPAP device outlet and the patient tube, and has an ISO taper connector to enable connection of the patient's tube and attachment to the CPAP device outlet.
Intervention code [1] 312522 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307583 0
The primary objective is the cross-correlation of the acoustic signals recorded from the patient environment and the external recording in the controlled laboratory environment.
Timepoint [1] 307583 0
Nightly for 7 nights
Secondary outcome [1] 352498 0
Descriptive statistics on:

*Device location

Assessed via Audit of participant nightly diary
Timepoint [1] 352498 0
Nightly for 7 nights

Eligibility
Key inclusion criteria
Patients willing to give written informed consent
Patients who can read and write English
Patients over 18 years of age
Patients established on CPAP therapy
Patients currently using an appropriate mask
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients using bilevel devices
Patients who are using supplemental oxygen
Patients who are or may be pregnant
Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury
Patients who are using another medical device concurrently
Patients believed unsuitable for inclusion by the researcher

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
12/11/2018
Actual
22/01/2019
Date of last participant enrolment
Anticipated
3/12/2018
Actual
29/01/2019
Date of last data collection
Anticipated
17/12/2018
Actual
5/02/2019
Sample size
Target
18
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300784 0
Commercial sector/Industry
Name [1] 300784 0
ResMed Ltd
Country [1] 300784 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ResMed Ltd
Address
1 Elizabeth Macarthur Drive
Bella Vista, NSW, 2153
Country
Australia
Secondary sponsor category [1] 300332 0
None
Name [1] 300332 0
Address [1] 300332 0
Country [1] 300332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301568 0
The University of New South Wales Research Ethics Committe
Ethics committee address [1] 301568 0
The University of New South Wales

Sydney NSW 2052 Australia
Ethics committee country [1] 301568 0
Australia
Date submitted for ethics approval [1] 301568 0
22/10/2018
Approval date [1] 301568 0
30/11/2018
Ethics approval number [1] 301568 0
HC180811

Summary
Brief summary
This study will look at the feasibility of using acoustic tools in the home environment to improve patient experience with CPAP therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87414 0
Dr Adam Benjafield
Address 87414 0
ResMed Ltd
1 Elizabeth Macathur Drive
Bella Vista, NSW 2153
Country 87414 0
Australia
Phone 87414 0
+61 2 8884 1000
Fax 87414 0
Email 87414 0
[email protected]
Contact person for public queries
Name 87415 0
Ms Alisha Middleton
Address 87415 0
ResMed Ltd
1 Elizabeth Macathur Drive
Bella Vista, NSW 2153
Country 87415 0
Australia
Phone 87415 0
+61 02 8884 1000
Fax 87415 0
Email 87415 0
[email protected]
Contact person for scientific queries
Name 87416 0
Ms Alisha Middleton
Address 87416 0
ResMed Ltd
1 Elizabeth Macathur Drive
Bella Vista, NSW 2153
Country 87416 0
Australia
Phone 87416 0
+61 02 8884 1000
Fax 87416 0
Email 87416 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data analysed and out in an internal report only. A summary report will shared be with ethics committee only.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 376089-(Uploaded-17-09-2019-09-57-12)-Basic results summary.docx
Plain language summaryNo The Mask Identification Clinical Study was a singl... [More Details]

Documents added automatically
No additional documents have been identified.