Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000719033
Ethics application status
Approved
Date submitted
25/08/2010
Date registered
30/08/2010
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Custom-fitting the mask-skin interface in continuous posititve airway pressure (CPAP) therapy: A randomised, best standard treatment controlled trial of compliance
Scientific title
Participants with moderate to severe sleep apnoea, randomised to receive continuous posititve airway pressure (CPAP) therapy with a custom-fitted or best-fit standard mask, assessed for compliance and consistency of use
Secondary ID [1] 252187 0
none
Universal Trial Number (UTN)
U1111-1115-9632
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep apnoea 257692 0
Condition category
Condition code
Respiratory 257867 257867 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CPAP treatment of sleep apnoea using a custom fitted mask (the TrueFIT Custom Mask). An impression is taken of the central features of the study participants face. The mask is made, the participant fitted with the mask and educated as to the use of the mask and the ResMed sleep apnea system. The ResMed is a 1.4 kg unit, 112 mm x 164 mm x 145 mm, operating from mains power. The system pumps air at a predetermined increased pressure to the mask and gathers information about mask usage. The participant is asked to use the mask and Resmed each night for a total of 1 year. The participant's technique with the mask and equipment is reviewed at each study visit, and further education provided as necessary.
Intervention code [1] 256763 0
Treatment: Devices
Comparator / control treatment
CPAP treatment of sleep apnoea using the best-fit commercially available standard mask. The mask is selected and fitted and the study participant educated as to the use of the mask and the ResMed positive pressure and recording system. The participant is asked to use the mask and Resmed each night for 1 year . The participant's technique with the mask and equipment is reviewed at each study visit, and further education provided as necessary.
Control group
Active

Outcomes
Primary outcome [1] 258743 0
Compliance (usage in hours per night) and consistency of use (nights used for more than 20 minutes)
Timepoint [1] 258743 0
12 weeks from baseline and 52 weeks from baseline
Secondary outcome [1] 264791 0
Tolerability, assessed by the number of treatment changes (mask change or adjustments, pressure adjustments), the frequency, severity and nature of expected adverse events (side effects), the frequency and severity of mask leaks, pressure range. Side effects include dry mouth, dry throat; a lot of saliva; sore gums or lips; skin soreness; eye irritation; blocked nose; claustrophobia; air leaks from the mask; air flow annoyance from the outlet port; mask coming off; pressure from the straps or the mask; and difficulty fitting the mask, and social consequences. Participants will be asked about side effects at follow up visits (weeks 4, 8, 12, 26 and 52).
Timepoint [1] 264791 0
52 weeks from baseline
Secondary outcome [2] 264792 0
Efficacy, assessed by the frequency, severity and nature of the physiologicial measures of disease severity (Apnoea Index, Apnoea Hypopnoea Index & snoring/events/amplitude/hour), daytime sleepiness and functional status
Timepoint [2] 264792 0
52 weeks from baseline
Secondary outcome [3] 264793 0
Cost effectiveness assessed by use of support services and equipment
Timepoint [3] 264793 0
52 weeks from baseline

Eligibility
Key inclusion criteria
Age 18 years or older
Diagnostic polysomnography at The Wesley Sleep Disorders Centre (TWSDC) with newly diagnosed moderate to severe obstructive sleep apnoea
Titration study at TWHDC and assessed as suitable for nasal CPAP therapy
Willing to comply with all study requirements
Able to understand and follow verbal and written instruction
Able to give written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical or psychological conditions which according to the investigator interfere with trial participation.
Previous CPAP treatment

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)
When a subject has signed the study Consent Form, they will be allocated the next participant number. The treatment allocations will be in opaque sealed envelopes. The corresponding envelope will be opened and the subject informed of the allocated treatment. (The study is open label.)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised algorithm was used to generate permuted block randomisations. Participants were equally randomised to treatment conditions within the blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257259 0
Commercial sector/Industry
Name [1] 257259 0
Acurest
Country [1] 257259 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Acurest
Address
Unit 53, South Pine Central, 302 South Pine Road, Brendale, Queensland 4500
Country
Australia
Secondary sponsor category [1] 256502 0
None
Name [1] 256502 0
Address [1] 256502 0
Country [1] 256502 0
Other collaborator category [1] 251371 0
Other Collaborative groups
Name [1] 251371 0
The Wesley Sleep Disorders Centre
Address [1] 251371 0
Level 9, Evan Thomson Building, 14 Chasely St (The Wesley Hospital), Auchenflower, Brisbane 4066
Country [1] 251371 0
Australia
Other collaborator category [2] 251378 0
Charities/Societies/Foundations
Name [2] 251378 0
The Wesley Research Institute
Address [2] 251378 0
Clinical Trials Centre, level MB2, Moorlands Wing, The Wesley Hospital, 451 Coronation Drive, Auchenflower, Brisbane, 4066
Country [2] 251378 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259275 0
Uniting HealthCare Research Ethics Committee
Ethics committee address [1] 259275 0
The Wesley Hospital, 451 Coronation Drive, Auchenflower, Brisbane 4066
Ethics committee country [1] 259275 0
Australia
Date submitted for ethics approval [1] 259275 0
05/05/2010
Approval date [1] 259275 0
30/06/2010
Ethics approval number [1] 259275 0
EC00374

Summary
Brief summary
People with newly diagnosed obstructive sleep apnoea for treatment with continuous positive airway pressure through a nasal mask (cPAP) are assigned to use a new custom fitted mask or the best-fit commercially available standard mask. There are 6 planned study visits over the 12 month treatment period. Participants are asked to complete study questionnaires at each study visit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31362 0
Address 31362 0
Country 31362 0
Phone 31362 0
Fax 31362 0
Email 31362 0
Contact person for public queries
Name 14609 0
Jade Pittard
Address 14609 0
The Wesley Sleep Disorders Centre, Level 9, Evan Thomson Building, 24 Chasely St (The Wesley Hospital), Auchenflower, Brisbane 4066
Country 14609 0
Australia
Phone 14609 0
+61 7 3870 1120
Fax 14609 0
+61 7 3870 0233
Email 14609 0
[email protected]
Contact person for scientific queries
Name 5537 0
Dr John Feenstra
Address 5537 0
Thoracic and Sleep Group Queensland, Level 9, Evan Thomson Building, 24 Chasely St (The Wesley Hospital), Auchenflower, Brisbane 4066
Country 5537 0
Australia
Phone 5537 0
+61 7 3870 1120
Fax 5537 0
+61 7 3870 0233
Email 5537 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
No additional documents have been identified.