Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001090303
Ethics application status
Approved
Date submitted
21/07/2017
Date registered
27/07/2017
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the usage of Continuous Positive Airway Pressure (PAP) against the RACer airway device in the treatment of Obstructive Sleep Apnoea (OSA) in naive PAP users.
Scientific title
Continuous Positive Airway Pressure versus RACer airway device in the treatment of obstructive sleep apnoea - Adherence in Naive PAP users
Secondary ID [1] 291905 0
None
Universal Trial Number (UTN)
U1111-1198-4354
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 303211 0
Condition category
Condition code
Respiratory 302646 302646 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to either the standard CPAP device or RACer airway device for the treatment of obstructive sleep apnoea. Arm 1: will involve 4 weeks using either of the medical devices at their home and include 2 follow up appointments in the lab. Arm 2: will involve another 4 weeks of treatment on the other device that was not used in arm 1 and again include 2 follow up appointments at the lab. There will be a 3-day washout period between arms. The RACer device combines two commercially available CPAP machine motors into 1 unit to deliver pressurised air into the upper airway into 1 nostril at a time. This is different to conventional PAP machines. Participants will use the RACer device the same as they use a standard PAP device, however they must use a nasal pillow mask as an interface for the pressurised air. Participants will use the RACer device at night, as a treatment for their sleep apnoea, for the entire 4 week period. RACer device settings will be entered for each individual participant following their initial sleep study and could be in a pressure range from 8 - 20 cm/H2O. The RACer device will objectively monitor usage each night, as well as AHI, and these will be downloaded at each follow up appointment.
Intervention code [1] 298026 0
Treatment: Devices
Comparator / control treatment
Standard CPAP therapy will act as a control for the RACer airway device therapy. The control in this study is within participants where they will be treated for obstructive sleep apnoea with standard CPAP therapy and the RACer device in separate blocks of 4 weeks with a 3-day wash out period between the 2 arms of the study. CPAP machines will be used each night by the participants for the treatment of their sleep apnoea. The therapy settings of each CPAP machine will be set appropriately for each individual participant following the initial sleep study and could be in a pressure range from 8 - 20 cm/H2O.
Control group
Active

Outcomes
Primary outcome [1] 302055 0
Objective adherence, measured as mean hours per night using treatment device, will be assessed by usage data downloaded from each device at follow-up appointments.
Timepoint [1] 302055 0
Measured over last 2 weeks of 4 week study arm.
Secondary outcome [1] 334640 0
Apnoea Hypopnoea Index (AHI), which is the number of apnoea and hypopnea events per hour on treatment, will be assessed by usage data downloaded from each device at follow-up appointments.
Timepoint [1] 334640 0
Measured during last 2 weeks of 4 week arm
Secondary outcome [2] 334641 0
Participants sleepiness will be assessed with the Epworth sleepiness score
Timepoint [2] 334641 0
Measured at baseline and 2 week and 4 week follow up appointments during both arms of the study.
Secondary outcome [3] 334642 0
Participants quality of life will be assessed with the SF36 questionnaire
Timepoint [3] 334642 0
Measured at baseline and 2 week and 4 week follow up appointments during both arms of the study.
Secondary outcome [4] 337344 0
Subjective comfort of each device will be assessed by an in-house questionnaire
Timepoint [4] 337344 0
Measured at both 2 and 4 week follow up appointments for each arm of the trial.

Eligibility
Key inclusion criteria
Adults (aged 18-70) , naive to PAP therapy, able to tolerate a nasal pillow mask type, moderate to severe OSA defined by an AHI or RDI of > 20 events per hour on a diagnostic sleep study (L 1, 2 or 3).
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Blood thinning medication, nasal obstruction, unable to tolerate nasal pillow mask type, excessive daytime sleepiness or safety critical occupation, unstable co-morbid medical conditions including heart failure, respiratory failure, arrhythmia, previous cerebrovascular accident.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Current WellSleep compliance at 1 month is approximately 5 +/- 1.5 hours per night. A sample of 30 subjects will mean that RACer will need to average 6.1 hours per night adherence for the study to show statistical significance with 80% power and a 5% Type I error rate

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/08/2017
Actual
20/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 8892 0
New Zealand
State/province [1] 8892 0
Wellington

Funding & Sponsors
Funding source category [1] 296413 0
University
Name [1] 296413 0
Auckland University of Technology (AUT) Enterprises Ltd
Country [1] 296413 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology (AUT) Enterprises Ltd
Address
55 Wellesley St E, Auckland, 1010
Country
New Zealand
Secondary sponsor category [1] 295356 0
None
Name [1] 295356 0
Address [1] 295356 0
Country [1] 295356 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297637 0
Health and Disability Ethics Committees
Ethics committee address [1] 297637 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 297637 0
New Zealand
Date submitted for ethics approval [1] 297637 0
13/07/2017
Approval date [1] 297637 0
02/08/2017
Ethics approval number [1] 297637 0
17/CEN/140

Summary
Brief summary
The adherence of the Racer system will be compared against standard positive airway pressure (PAP) machines in a group of naive PAP users. Patients will have been clinically recommended to begin PAP treatment for moderate to severe obstructive sleep apnoea (OSA). Following an initial level 1, 2 or 3 sleep study and PAP pressure auto-titration in the WellSleep lab, subjects will use either a continuous PAP (CPAP) device or RACer device for 8 weeks in their own home in a random order with a 3 day wash-out period between devices. Patients will use both the RACer and/or standard PAP therapy to determine which system has the greatest adherence over 4 weeks of use. Patients will visit the WellSleep lab every 2 weeks for follow-up appointments, which will involve an appointment with a sleep technician to problem solve any issues with the treatment that may arise, as well as to complete questionnaires relating to the comfort of each device, the participants sleepiness score and a short quality of life questionnaire.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1969 1969 0 0
/AnzctrAttachments/372904-HDEC Letter 17CEN140_Approved EXP Application with non std conditions.pdf (Ethics approval)

Contacts
Principal investigator
Name 74674 0
Dr Angela Campbell
Address 74674 0
WellSleep,
University of Otago, Wellington
98 Churchill Drive,
Crofton Downs, 6035
Wellington
Country 74674 0
New Zealand
Phone 74674 0
+64 4 920 8819
Fax 74674 0
Email 74674 0
[email protected]
Contact person for public queries
Name 74675 0
Dr Angela Campbell
Address 74675 0
WellSleep,
University of Otago, Wellington
98 Churchill Drive
Crofton Downs, 6035
Wellington
Country 74675 0
New Zealand
Phone 74675 0
+64 4 920 8819
Fax 74675 0
Email 74675 0
[email protected]
Contact person for scientific queries
Name 74676 0
Mr James Miller
Address 74676 0
WellSleep,
University of Otago, Wellington
98 Churchill Drive
Crofton Downs, 6035
Wellington
Country 74676 0
New Zealand
Phone 74676 0
+64 4 920 8819
Fax 74676 0
Email 74676 0
[email protected]

No information has been provided regarding IPD availability


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
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