Obstructive Sleep Apnea
Conditions
Brief summary
Currently Fisher & Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear. The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.
Interventions
DEVICEInvestigative Full Face Mask with Headgear
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* AHI ≥ 5 from the diagnostic night * ≥ 18 years of age * Either prescribed APAP or CPAP or Bi level for OSA * Existing full face users
Exclusion criteria
* Inability to give informed consent * Participant intolerance to PAP * Anatomical or physiological conditions making PAP therapy inappropriate * Current diagnosis of respiratory disease or CO2 retention * Pregnant or think they may be pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The mask is comfortable and is effective for the participant during in-home use | 1 week for each mask prototype in-home | Performance in relations to leak and comfort of each prototype and how it compares to their usual mask, as measured by a custom questionnaire, daily participant feedback log and PAP device data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the Full Face mask prototypes | 1 week for each mask prototype in-home | Preference for one of the Full Face Mask prototypes design through a custom questionnaire and a daily participant feedback log |
Countries
New Zealand
Outcome results
None listed