ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000029291

Ethics application status

Approved

Date submitted

8/10/2008

Date registered

16/01/2009

Date last updated

27/02/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

A comparison of the use of different types of continous positive airway pressure (CPAP) masks to control leaks and improve patient comfort

Scientific title

A comparison of continous positive airway pressure (CPAP) interface in the control of leak, patient compliance and patient preference: nasal CPAP mask and chinstrap versus full face mask in patients with obstructive sleep apnoea (OSA).

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obstructive Sleep Apnoea (OSA)

Condition category

Condition code

Respiratory

Sleep apnoea

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Randomised crossover trial to compare three continuous positive airway pressure (CPAP) mask options. Nasal mask, using "best fit" from a variety of nasal masks with and without a chinstrap, and"best fit" from a variety of full face masks in control of CPAP pressure leak. All masks are fitted by experienced trained nurses. Patients wear each of the three interface options consecutively for a period of one month, in a predetermined random order.Patients are instructed to wear each of the three interface options whenever sleeping (day or night) for each study month. Data is collected for weeks 3 and 4 of use, to allow for a period of acclimatisation to each new set up.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Not applicable

Comparator / control treatment

There are three masks being compared as described in the intervention field.

Control group

Active

Outcomes

Primary outcome [1]

CPAP compliance (mean hours of use)

Timepoint [1]

1 month, 2 months, 3 months

Secondary outcome [1]

minutes in large leak- data available from continuous positive airway pressure (CPAP) pump data download

Timepoint [1]

1 month, 2 months, 3 months

Secondary outcome [2]

Epworth Sleepiness Score which measures daytime sleepiness as a score out of 24. Less than 10/24 is acceptable as normal.

Timepoint [2]

baseline, 1 month, 2 months, 3 months

Secondary outcome [3]

CPAP mask preference- Patients will be asked which is their preferred mask option.

Timepoint [3]

3 months

Secondary outcome [4]

Quality of sleep measured by Likert Scale of 0-10. The higher the score the higher the quality of sleep.

Timepoint [4]

1 month, 2 months, 3 months

Eligibility

Key inclusion criteria

Prescribed CPAP therapy to treat OSA
Able to breathe comfortably through nose
Not used CPAP previously

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Unable to breathe through nose
Inability to tolerate CPAP
Unstable psychiatric illnes
Previous surgical intervention for OSA
Previous use of CPAP > 1 week

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)

All patients tried all three interface types i.e. nasal mask, nasal and chin-strap, full face mask. The order in which they used the interfaces was randomised. Once patients had consented to trial an envelope was opened and this contained a piece of paper with the mask sequence written upon it.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

We determined that at least 40 participants were required to give sufficient power to the study and allowing for a number of dropouts that we needed to enrol at least 54 patients. Equal numbers of the six possible combinations for order of mask use were printed on slips of paper. These were folded and placed into sealed envelopes by one researcher and then numbered for order of use by another .

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Each type of interface was used for a period of 4 weeks and then patients were reviewed and the interface changed. The specific style and brand of interface for each type was varied and chosen for best fit/seal. Only one chinstrap was used. CPAP compliance and leak data collated for weeks 3 and 4 of each mask used so that patients had a 2 week acclimatisation period for each new interface type.
Patients completed a mask satifaction questionnaire and Epworth Sleepiness score at each reveiw.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2007

Actual

1/06/2007

Date of last participant enrolment

Anticipated

Actual

24/07/2008

Date of last data collection

Anticipated

Actual

23/10/2008

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Foundation Daw Park

Address [1]

Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041

Country [1]

Australia

Primary sponsor type

Hospital

Name

Adelaide Institute for Sleep Health

Address

Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Sharn Rowland

Address [1]

Adelaide Institute for Sleep Health
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Cathy Hennessy

Address [1]

Adelaide Institute for Sleep Health
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Repatriation General Hospital

Ethics committee address [1]

206-216 Daws Rd
DAW PARK
SA 5041

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/12/2006

Approval date [1]

19/12/2006

Ethics approval number [1]

64/06

Summary

Brief summary

Continuous positive airway pressure (CPAP) is the treatment of choice for OSA. The CPAP pressure is delivered via a mask worn over the nose or the nose and mouth. If air leaks from the mouth or around the mask  whilst being used, the treatment is not as effective  and the patient may find it uncomfortable and not use it. We have two options to control mouth leaks , add a chinstrap to a nasal mask or change to a full face mask.We do not know which is the best option.  The full face mask may leak more and is more expensive but the chin strap may not work. 
Also patients may find that one option is easier to use and more comfortable.

Trial website

Trial related presentations / publications

4/10/2008 Australasian Sleep Association Annual scientific meeting-  poster and 5 minute presentation.

Public notes

Contacts

Principal investigator

Name

Mrs L Sharn Rowland

Address

Sleep Health Service SALHN
Repatriation General Hospital
Daws Rd
Daw Park
SA 5049

Country

Australia

Phone

+61 08 82751187

Fax

sharn.rowland@sa.gov.au

Contact person for public queries

Name

Sharn Rowland

Address

Adelaide Institute for Sleep Health
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041

Country

Australia

Phone

+61 8 82751822

Fax

sharn.rowland@sa.gov.au

Contact person for scientific queries

Name

Sharn Rowland

Address

Adelaide Institute for Sleep Health
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041

Country

Australia

Phone

+61 8 82751822

Fax

sharn.rowland@sa.gov.au

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

Source	Title	Year of Publication	DOI
Embase	Comparing the efficacy, mask leak, patient adherence, and patient preference of three different CPAP interfaces to treat moderate-severe obstructive sleep apnea.	2018	https://dx.doi.org/10.5664/jcsm.6892

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically