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The investigation of different masks for positive airway pressure therapy for Obstructive Sleep Apnea (OSA)

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000621617
Enrollment
270
Registered
2014-06-11
Start date
2014-06-03
Completion date
2014-06-03
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

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.

Interventions

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 partic

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.

Sponsors

Fisher & Paykel Healthcare
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026