Skip to content

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

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).

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000029291
Enrollment
48
Registered
2009-01-16
Start date
2007-06-01
Completion date
2008-07-24
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 in

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.

Sponsors

Adelaide Institute for Sleep Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 7, 2026