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Trial registered on ANZCTR


Registration number
ACTRN12614000621617
Ethics application status
Approved
Date submitted
27/05/2014
Date registered
11/06/2014
Date last updated
27/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The investigation of different masks for positive airway pressure therapy for Obstructive Sleep Apnea (OSA)
Scientific title
An evaluation of different masks - nasal, nasal pillows, full face for the treatment for obstructive sleep apnea in association with comfort, ease of use, treatment efficacy and compliance.
Secondary ID [1] 284626 0
None
Universal Trial Number (UTN)
U1111-1152-4630
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 291940 0
Condition category
Condition code
Respiratory 292293 292293 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions used in this clinical trial will be in the form of testing prototype masks on patients with obstructive sleep apnea. These masks may be any type - nasal, nasal pillows or full face. Up to 300 participants will be tested. Each mask will be provided to the patient to use either in-lab for one night or at home for up to 6 months at their prescribed CPAP pressure. This is to help with designing masks for OSA therapy that would be comfortable and easy to use for patients. The participants might be asked to test multiple masks at different timepoint, however wash-out period is not required as evaluating comfort and the ease of use are the main objectives. CPAP data will be downloaded to see the effectiveness of the trial mask in its treatment.

Three different types of mask will be tested in this study - nasal, nasal pillows and full face. There may be iterations of each type of mask depending upon the feedback provided. A nasal mask provides positive pressure therapy to patient via the nose, with the mask fitting over the nose. A nasal pillows mask provides positive pressure therapy via the nose, with the mask fitting into the nares/nostrils. A full face mask provides positive pressure therapy via the nose and mouth, with the mask fitting over both. Participants are allocated to the same mask delivery that they are used to (i.e. nasal mask users will receive a prototype nasal mask, nasal pillows will receive a prototype nasal pillows, full face mask users will receive a prototype full face). Only one mask will be tested at a time – the comparison is to their usual/existing mask.

Intervention code [1] 289410 0
Treatment: Devices
Comparator / control treatment
Different masks might be tested in order to compare the effectiveness of the trial masks. However only masks from the same mask category will be tested at a time, e.g nasal vs nasal, will be compared.
Control group
Active

Outcomes
Primary outcome [1] 292158 0
Subjective mask performance in relation to comfort and ease of use via a custom patient’s feedback questionnaire and an interview conducted at the end of the trial.
Timepoint [1] 292158 0
One night of a sleep lab study or up to 6 months in home use
Secondary outcome [1] 308326 0
Objective mask performance in relation to the seal, via measuring mask leak through a flowmeter or PAP therapy device data.
Timepoint [1] 308326 0
One night of a sleep study or up to 6 months of in home use

Eligibility
Key inclusion criteria
18 years of age or older
Diagnosed OSA with an AHI = 5 or more than 5
Prescribed CPAP or Bilevel therapy by a practicing sleep/respiratory physician
Are able to consent to take part in the trial
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent
Pregnant or think they may be pregnant
Currently being investigated by the Land Transport Safety Authority
History of respiratory disease or CO2 retention

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)
Subjects will be enrolled as diagnosed OSA patient prescribed with CPAP or Bi-level from the stated localities.

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)
All subjects will use the trial mask therefore randomization is not required.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6067 0
New Zealand
State/province [1] 6067 0

Funding & Sponsors
Funding source category [1] 289272 0
Commercial sector/Industry
Name [1] 289272 0
Fisher & Paykel Healthcare
Address [1] 289272 0
15 Maurice Paykel Place
East Tamaki
Auckland
2013
Country [1] 289272 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] 287946 0
None
Name [1] 287946 0
Address [1] 287946 0
Country [1] 287946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291043 0
NZ Health & Disability Ethics Committees
Ethics committee address [1] 291043 0
Ministry of Health
1 The Terrace
PO Box 5013
Wellington
6011
Ethics committee country [1] 291043 0
New Zealand
Date submitted for ethics approval [1] 291043 0
15/04/2014
Approval date [1] 291043 0
29/05/2014
Ethics approval number [1] 291043 0
14/NTA/58

Summary
Brief summary
Positive Airway Pressure (PAP) therapy through continuous positive airway pressure (CPAP) and Bi-PAP are used to treat patients with Obstructive Sleep Apnea (OSA). PAP therapy requires the delivery of pressurized air to the oronasal areas via an interface. Despite the effectiveness of CPAP and Bi-PAP in abolishing upper airway obstruction, acceptance of and adherence with therapy has been sub-optimal. Reasons for the low compliance include nocturnal awakenings, incorrect therapeutic pressure and primarily discomfort due to poor mask fit. Poor mask fit can result in facial abrasion, leak causing fluctuations in therapeutic pressure and irritation of the eyes. There are continuous improvements on interfaces and it requires evaluation for comfort and acceptance. The purpose of this study is to evaluate the efficacy of a range of PAP interfaces to improve comfort and compliance for PAP therapy.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 48526 0
Miss Irene Cheung
Address 48526 0
Fisher & Paykel Healthcare 15 Maurice Paykel Place East Tamaki Auckland 2013
Country 48526 0
New Zealand
Phone 48526 0
+64 9 5740123 7889
Fax 48526 0
Email 48526 0
irene.cheung@fphcare.co.nz
Contact person for public queries
Name 48527 0
Ms Bhavi Ogra
Address 48527 0
Fisher & Paykel Healthcare 15 Maurice Paykel Place East Tamaki Auckland 2013
Country 48527 0
New Zealand
Phone 48527 0
+64 9 5740123 7882
Fax 48527 0
Email 48527 0
Bhavi.Ogra@fphcare.co.nz
Contact person for scientific queries
Name 48528 0
Ms Bhavi Ogra
Address 48528 0
Fisher & Paykel Healthcare 15 Maurice Paykel Place East Tamaki Auckland 2013
Country 48528 0
New Zealand
Phone 48528 0
+64 9 5740123 7882
Fax 48528 0
Email 48528 0
Bhavi.Ogra@fphcare.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary