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

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 trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants. An important factor in this investigation will be the testing of two different seal sizes on the participants (medium and large size). A total number of 12 participants who currently use nasal or nasal pillow masks will be recruited for the trial. Participants have been selected based on their anthropometric measurements collected in previous trials (CIA-103). 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 use the trial mask in home for a period of 7 ± 3 days and also 1 overnight polysomnography session at the Fisher & Paykel Healthcare sleep lab. Baseline data will be collected from the participant during the first visit, 7 days of CPAP usage data will be downloaded and stored for analysis. 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 trial.

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

Conditions
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Sleep Disordered Breathing, Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Trial Nasal mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (18+ years of age) Able to give consent Apnea Hypopnea Index (AHI) ≥ 5 on diagnostic night Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis Existing nasal or nasal pillow 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 (e.g. unconsolidated facial structure) 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: Trial Nasal Mask<br>Participants to use nasal mask in-home for a week and one night in lab overnight polysomnography. | Device: Trial Nasal mask<br>* Nasal 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 |
| --- | --- | --- |
| Objective leak data (L/min) | Obtained from the participant's device | Up to 1 week in-home | 
| Subjective measurement of leak | Subjective Questionnaire | Up to 1 week in-home | 
| Comfort | Subjective Questionnaire | Up to 1 week in-home | 
| Stability | Subjective Questionnaire | Up to 1 week in-home | 
| Draft | Subjective Questionnaire | Up to 1 week in-home | 
| Noise | Subjective Questionnaire | Up to 1 week in-home | 
| Objective leak data (L/min) | Obtained from the overnight polysomnography | 1 night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference of the mask | Subjective Questionnaire | Up to 1 week in-home |