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

Study Overview
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Brief Summary
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This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.

Official Title
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Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: New nasal pillows mask with PAP therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are ≥22 years of age Weigh ≥66 lbs Have been formally diagnosed with OSA by a physician Have an AHI ≥5 on a diagnostic night Have been prescribed PAP therapy to treat OSA by a physician Are an existing nasal pillows mask user Have been using a nasal pillows mask for ≥3 months prior to enrolment into the study Are compliant with PAP therapy for ≥4 hours per night for 70% of nights Are fluent in spoken and written English Possess the capacity to provide informed consent Exclusion Criteria: Are intolerant to PAP therapy Possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate Are currently diagnosed with respiratory disease or CO2 retention Are pregnant or think they may be pregnant Have an IPAP pressure of >25 cmH2O Persons who use a PAP therapy machine for the delivery of medicines, except O2 Use a PAP therapy machine that does not possess data recording capabilities to capture AHI and leak information that is accessible to OSMI

Ages Eligible for Study
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Minimum Age: 22 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
Interventional Model Description: After the baseline period, all participants will be trialed on the same new nasal pillows mask.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy. | Device: New nasal pillows mask with PAP therapy<br>* Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of new nasal pillows mask | The new nasal pillows mask provides adequate PAP therapy for OSA when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines. | 14±5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort of new nasal pillows mask | The new nasal pillows mask is comfortable during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire. | 14±5 days | 
| Usability of new nasal pillows mask | The new nasal pillows mask is user-friendly during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire. | 14±5 days |