Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000709246
Ethics application status
Approved
Date submitted
24/04/2018
Date registered
1/05/2018
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Breathing platform for relaxation
Scientific title
Take-home study assessing the usability of a breathing platform for relaxation in healthy participants
Secondary ID [1] 294705 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 307578 0
Condition category
Condition code
Respiratory 306647 306647 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The breathing platform will use a continuous positive air pressure (CPAP) device controlled by an app. Device and mobile phone (to run app) will be provided to participants by investigators on day 1 of the study. The device settings will include a pressure delivery between 4 and 20 cmH2O. Treatment session will involve starting their CPAP (with the 'on' button) and using the app for breathing instructions. Intended frequency of intervention involves 10-30 mins of therapy per day, for 4 days. Feedback & compliance will be logged in interview at day 5.
Intervention code [1] 301001 0
Treatment: Devices
Comparator / control treatment
The control treatment will involve exactly the same parameters as the intervention, just without assistance from the investigational device (with mobile phone app only). Treatment will involve the same duration, location and procedure just without the assistance of the device. Feedback and compliance will still be assessed in an interview after the completion of the study.
Control group
Active

Outcomes
Primary outcome [1] 305643 0
Assess the usability of the system assessed by scores allocated by participants regarding the ease of use (scale from 1-10).
Timepoint [1] 305643 0
Usability will be assessed halfway (day 5) during the trial and at the completion of the study (after day 8 - primary timepoint).
Secondary outcome [1] 346015 0
Compliance to treatment will be assessed in an interview between the participant and investigator.
Timepoint [1] 346015 0
Interview will be held at the completion of the study - day 9

Eligibility
Key inclusion criteria
• Participants are willing to give written, informed consent
• Participants are healthy adults
• Participants are able to comprehend and speak English
• Participants are at least 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Participants who are/may be pregnant or lactating
• Participants that have a pre-existing 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)
• Participants who are unsuitable for the inclusion at the discretion of the investigator

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)
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/05/2018
Actual
11/06/2018
Date of last participant enrolment
Anticipated
31/08/2018
Actual
14/06/2018
Date of last data collection
Anticipated
31/12/2018
Actual
13/07/2018
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299310 0
Commercial sector/Industry
Name [1] 299310 0
ResMed
Country [1] 299310 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
ResMed Ltd
1 Elizabeth MacArthur Drive,
Bella Vista NSW 2153
Country
Australia
Secondary sponsor category [1] 298579 0
None
Name [1] 298579 0
Address [1] 298579 0
Country [1] 298579 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300220 0
UNSW HREC
Ethics committee address [1] 300220 0
Ethics committee country [1] 300220 0
Australia
Date submitted for ethics approval [1] 300220 0
30/04/2018
Approval date [1] 300220 0
06/06/2018
Ethics approval number [1] 300220 0

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

Contacts
Principal investigator
Name 82958 0
Dr Jeff Armitstead
Address 82958 0
ResMed Ltd
1 Elizabeth MacArthur Drive,
Bella Vista NSW 2153
Country 82958 0
Australia
Phone 82958 0
+612 8884 1000
Fax 82958 0
Email 82958 0
[email protected]
Contact person for public queries
Name 82959 0
Lisa Matthews
Address 82959 0
ResMed Ltd
1 Elizabeth MacArthur Drive,
Bella Vista NSW 2153
Country 82959 0
Australia
Phone 82959 0
+612 88841860
Fax 82959 0
Email 82959 0
[email protected]
Contact person for scientific queries
Name 82960 0
Lisa Matthews
Address 82960 0
ResMed Ltd
1 Elizabeth MacArthur Drive,
Bella Vista NSW 2153
Country 82960 0
Australia
Phone 82960 0
+612 88841860
Fax 82960 0
Email 82960 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
Intellectual property of the company.


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.