The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ

Study Overview
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Brief Summary
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This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants. Also to assist in the development process it would be beneficial to get feedback from users on certain aspects of the design. The aim of this investigation is to get feedback on the first impressions (look and feel) from users of nasal pillows PAP therapy. A total number of 15 participants who currently use a nasal pillows mask will be recruited for the trial. Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher & Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI). Participants will undergo an overnight polysomnography session at the Fisher & Paykel Healthcare sleep lab. The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the overnight in-lab study.

Official Title
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The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: New Nasal Pillows Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (18+ years of age) Able to give consent AHI ≥ 5 on diagnostic night Prescribed a CPAP device after successful OSA diagnosis Existing nasal pillows mask user Exclusion Criteria: Inability to give consent Patients who are in a coma or a decreased level of consciousness. Anatomical or physiological conditions making APAP therapy inappropriate Commercial drivers who are investigated by New Zealand Transport Agency (NZTA) Current diagnosis of CO2 retention Pregnant or may think they are pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Nasal Pillows Mask<br>Participants to use nasal pillows mask one night in lab overnight polysomnography. | Device: New Nasal Pillows Mask<br>* Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Initial Impressions of the Toffee Nasal Pillows Mask Assessed Using a Custom Questionnaire | Participants choose the Toffee mask based on first impressions over 3 market leading masks. | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort of the Toffee Nasal Pillows Mask Assessed Using a Custom Questionnaire | Participants consider the Toffee mask to be as comfortable, or much more comfortable than their usual mask. | 12 hours | 
| Usability of the Toffee Nasal Pillows Mask Assessed With Visual Observations | Participants consider the Toffee mask to be easier or much easier to fit and adjust than their current mask | 12 hours |