Obstructive Sleep Apnea
Conditions
Brief summary
Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask. This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy. Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.
Interventions
DEVICETrial Nasal Mask
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18+ * Diagnosed with Ostructive Sleep Apnea by a practicing physician or clinicans * Existing nasal or nasal pillows user * Prescribed Positive Airway Pressure therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))
Exclusion criteria
* Inability to give informed consent * Pregnant or think they may be pregnant * Anatomical or physiological conditions making Positive Airway Pressure therapy inappropriate (e.g unconsolidated facial fracture) * Patients who are in a coma or decreased level of consciousness * Current diagnosis of CO2 retention * Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire | 2 weeks in home |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seal performance of the trial Nasal mask as measured by the subjective perception of leak through a custom questionnaire, in addition to objective leak data and treatment efficacy through the Positive Airway Pressure therapy device. | 2 weeks in home | the participant would choose from a 5 point likert scale on a questionnaire. The scale range from very good to very poor |
| Objective leak data through the Positive Airway Pressure therapy device | 2 weeks in home | Evaluating the leak of the trial Nasal mask |
| Treatment efficacy through the Positive Airway Pressure therapy device | 2 weeks in home | Evaluating the number of apnea/hypopnea per hour |
| Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire. | 2 weeks in home | the participant would either choose the trial Nasal mask or their usual mask as their primary mask |
Countries
New Zealand
Outcome results
None listed