An Investigation to Test a Prototype Full-face Mask in the Home Setting

Study Overview
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Brief Summary
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This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial.

Detailed Description
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This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects with OSA (Ethics reference NTY/08/06/064), Auckland District Health Board (ADHB), or WellSleep Centre (Bowen Hospital, Wellington, NZ). Participants will be on the trial for 21 days ± 6 days, using the prototypes at home for 14 days ± 3 days. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for 7 days ± 3 days prior to mask fitting with the Jupiter trial mask. Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation. 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 (Bhavi Ogra) as soon as possible.

Official Title
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An Investigation to Test a Prototype Full-face Mask in the Home Setting

Conditions
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Sleep Disordered Breathing, Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Jupiter Full Face Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 18+ years of age Diagnosed with OSA by a practicing physician Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP)). Patient can be naïve to CPAP therapy or experienced (6 months and more) Existing full face mask users Patients who are able to put on and remove their current mask without gross difficulty relating to an existing condition (e.g. arthritis of the hands). Exclusion Criteria Inability to give informed consent Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture) Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA) Current diagnosis of CO2 retention Pregnant or think they may be 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: Jupiter Full Face Mask<br>Participants to use full face mask in-home for a 14 ± 3 days in-home. | Device: Jupiter Full Face Mask<br>* Full Face Mask for the treatment of obstructive sleep apnea (OSA) using CPAP therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective mask leak data measurement (System Leak) | Obtained from participant's CPAP device, measured in L/min | Up to 21 ± 6 days in-home | 
| Subjective Measurement of leak assessed using a Subjective Questionnaire | Subjective Questionnaire | Up to 21 ± 6 days in-home | 
| Comfort assessed using a Subjective Questionnaire | Subjective Questionnaire | Up to 21 ± 6 days in-home | 
| Stability assessed using a Subjective Questionnaire | Subjective Questionnaire | Up to 21 ± 6 days in-home | 
| Draft assessed using a Subjective Questionnaire | Subjective Questionnaire | Up to 21 ± 6 days in-home | 
| Noise assessed using a Subjective Questionnaire | Subjective Questionnaire | Up to 21 ± 6 days in-home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference of Mask assessed using a Subjective Questionnaire | Subjective Questionnaire | Up to 21 ± 6 days in-home | 
| Usability via mask unboxing/fitting exercise with a subjective questionnaire | Usability activity during visit 2 with subjective questionnaire after activity | Up to 21 ± 6 days in-home |