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Trial registered on ANZCTR


Registration number
ACTRN12613000712707
Ethics application status
Approved
Date submitted
25/06/2013
Date registered
28/06/2013
Date last updated
5/02/2020
Date data sharing statement initially provided
5/02/2020
Date results provided
5/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous Positive Airway Pressure(CPAP) Therapy Comfort
Scientific title
An evaluation of the comfort of modified CPAP devices in patients with obstructive sleep apnoea
Secondary ID [1] 282728 0
CIA-098 (Fisher & Paykel Healthcare)
Universal Trial Number (UTN)
1111-1142-7969
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 289458 0
Condition category
Condition code
Respiratory 289774 289774 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CPAP devices with modifications designed to increase patient comfort - to be trialled by subjects for comfort and preference only. 1. Two different devices will be trialled, each offering a different pressure control method (how stable the pressure is when breathing in and out). Device 1 will keep the pressure in the mask as low as possible. Device 2 will provide some pressure relief on expiration (in the region of 1-2cmH2O). 2.a) Subjects will breathe on the device while awake for short periods of time (minimum of 2 minutes and < 30 minutes) b) Patients will be tested on a sub-therapeutic pressure (as they are awake and don't require treatment). This pressure is determined by the minimum pressure the device can produce whilst safely flushing CO2. c) All participants will try all devices. The wash-out period between devices will be at least half as long as the time spent breathing on the device (between one minute and 15 minutes). Different mask prototytpes will be trialled with CPAP while the patient is awake.
Intervention code [1] 287391 0
Treatment: Devices
Comparator / control treatment
CPAP at a fixed pressure of 4cmH2O (awake pressure in devices that are currently available). CPAP will also be administered for < 30 minutes, while the subject is awake. Although CPAP pressure is fixed, there are normally small fluctuations in pressure at the patient interface (mask) as the patient inspires and expires.
Control group
Active

Outcomes
Primary outcome [1] 289858 0
Patient comfort (as assessed by a visaul analogue scale and questionnaires). These scales/questionnaires are designed specifically for the study
Timepoint [1] 289858 0
Initial exposure to CPAP treatment (i.e not on therapy), on completion of each testing period (<10 minutes)
Secondary outcome [1] 303400 0
Patient preference (assessed by questionnaire - which is designed specifically for the study).
Timepoint [1] 303400 0
Initial exposure to treatment, on completion of each testing period (<10 minutes)
Secondary outcome [2] 379643 0
The ease of use with each devices/masks, as measured by a custom designed ease of use questionnaire/usability script.
Timepoint [2] 379643 0
Initial exposure to treatment, on completion of each testing period (< 10 minutes)

Eligibility
Key inclusion criteria
Aged 18 years or older
Able to give informed consent

(this study will include healthy volunteers, patients that are awaiting a sleep study with a suspicion of OSA, and patients diagnosed with OSA)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contraindicated for CPAP/AutoCPAP therapy
Must not require supplemental oxygen
Must not have critical medical device (i.e. cardiac pacemaker)

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)
Subjects will be enrolled as healthy volunteers, diagnosed with OSA or suspicion of having OSA (before their diagnosing sleep study).

Allocation is concealed as it is completed by computer prior to enrolment of the subject (i.e. the randomisdation order is set by subject number, prior to subjects being enrolled and being given their subject number. Subject numbers are given in ascending order by enrolment time and date.)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomised (all subjects will receive the same test devices) but the devices will be randomised into different order to prevent order bias. This randomisation order is calculated using computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Design will inform safety/efficacy, but primary endpoint is initial patient comfort. Safety/efficacy data will be fulffilled in later testing (to be covered under different trial)
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This trial is to inform product development, and as such does not have a statistical plan. Any products highlighted for further development will undergo further product testing and validation to be considered under further trials.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/07/2013
Actual
15/07/2013
Date of last participant enrolment
Anticipated
Actual
21/09/2015
Date of last data collection
Anticipated
Actual
21/09/2015
Sample size
Target
200
Accrual to date
Final
161
Recruitment outside Australia
Country [1] 5162 0
New Zealand
State/province [1] 5162 0
Auckland

Funding & Sponsors
Funding source category [1] 287502 0
Commercial sector/Industry
Name [1] 287502 0
Fisher & Paykel Healthcare
Country [1] 287502 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
15 Maurice Paykel Place
East Tamaki
Auckland
2013
Country
New Zealand
Secondary sponsor category [1] 286240 0
None
Name [1] 286240 0
Address [1] 286240 0
Country [1] 286240 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289478 0
NZ Health & Disability Ethics Committees
Ethics committee address [1] 289478 0
Ethics committee country [1] 289478 0
New Zealand
Date submitted for ethics approval [1] 289478 0
10/05/2013
Approval date [1] 289478 0
17/06/2013
Ethics approval number [1] 289478 0
13/NRB/63

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

Contacts
Principal investigator
Name 41014 0
Dr Rachel Vicars
Address 41014 0
Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country 41014 0
New Zealand
Phone 41014 0
+64 9 5740123 7759
Fax 41014 0
Email 41014 0
[email protected]
Contact person for public queries
Name 41015 0
Hansinie Laing
Address 41015 0
Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country 41015 0
New Zealand
Phone 41015 0
+64 9 5740123 8601
Fax 41015 0
Email 41015 0
[email protected]
Contact person for scientific queries
Name 41016 0
Hansinie Laing
Address 41016 0
Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country 41016 0
New Zealand
Phone 41016 0
+64 9 5740123 8601
Fax 41016 0
Email 41016 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


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.