Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand

Study Overview
=================
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.

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Trial Nasal Mask


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial Nasal Mask<br>The participant will use the Saturn nasal mask for 2 weeks in home | Device: Trial Nasal Mask<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire |  | 2 weeks in home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | the participant would choose from a 5 point likert scale on a questionnaire. The scale range from very good to very poor | 2 weeks in home | 
| Objective leak data through the Positive Airway Pressure therapy device | Evaluating the leak of the trial Nasal mask | 2 weeks in home | 
| Treatment efficacy through the Positive Airway Pressure therapy device | Evaluating the number of apnea/hypopnea per hour | 2 weeks in home | 
| Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire. | the participant would either choose the trial Nasal mask or their usual mask as their primary mask | 2 weeks in home |