The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial

Study Overview
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Brief Summary
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This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA participants. An important factor in this investigation will be the testing of our two different seal sizes on the participants (small and medium size). A total number of 15 participants who currently use nasal or nasal pillow masks will be recruited for the trial. A subset of participants have been selected based on their anthropometric measurements collected in previous trials using nasal and nasal pillow masks at this site (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited by WellSleep, Wellington. Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will be collected from the participant during the first visit, the prior 7 days of CPAP usage data will be downloaded and stored for our analysis. The participant will use the trial device on their usual CPAP/APAP setting and device for the duration of the trial. This study will be conducted in accordance with ICH/GCP guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor as soon as possible.

Official Title
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The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial

Conditions
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Sleep Disordered Breathing, Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Saturn 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 AHI ≥ 5 on diagnostic night Prescribed a CPAP device after successful OSA diagnosis Existing nasal or nasal pillow mask user Exclusion Criteria: Inability to give consent Participants 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: Saturn nasal mask<br>Participants to use nasal mask in-home for 7 ± 3 days | Device: Saturn 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 |
| --- | --- | --- |
| Comfort | Subjective questionnaire | Up to 7 ± 3 days in-home | 
| Stability | Subjective questionnaire | Up to 7 ± 3 days in-home | 
| Objective leak data | Obtained from participant's CPAP device | Up to 7 ± 3 days in-home | 
| Subjective measurement of leak | Subjective questionnaire | Up to 7 ± 3 days in-home | 
| Draft | Subjective questionnaire | Up to 7 ± 3 days in-home | 
| Treatment efficacy | Obtained from participant's CPAP device | Up to 7 ± 3 days in-home | 
| Noise | Subjective questionnaire | Up to 7 ± 3 days in-home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference of mask | Subjective questionnaire | Up to 7 ± 3 days in-home | 
| Usability | Subjective questionnaire | Up to 7 ± 3 days in-home |