An Investigation to Test a Prototype Nasal 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 to test the interpretation of user instructions of a prototype nasal mask on participants. The clinical investigation will be conducted in New Zealand and participants will interact with the user instructions in a one hour daytime visit. A minimum of 15 participants will participate in this trial.

Detailed Description
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This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants. The clinical investigation will be conducted in New Zealand and participants will interact with the user instructions in a one hour daytime visit. This investigation is designed to evaluate the interpretation by participants of the user instructions. A total number of 20 participants, diagnosed with OSA will be recruited for the trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects (Ethics reference 18/NTA/62). 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 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 Nasal Mask in the Home Setting

Conditions
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Sleep Disordered Breathing, Obstructive Sleep Apnea

Intervention / Treatment
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* Device: User Instructions of novel nasal mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OSA Mask Users 18+ years of age Ability to give informed consent Exclusion Criteria: Inability to give informed consent

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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Accepts Healthy Volunteers

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: Arm<br>Experimental: User Instructions of a Novel Nasal Mask Participants to interpret user instructions in a one hour daytime visit. | Device: User Instructions of novel nasal mask<br>* User Unstructions interpretation of novel 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 |
| --- | --- | --- |
| Mask User Instructions Interpretation | Determined as interpreted by participants from open-ended questions (Open ended questionnaire, very easy - very difficult)- Subjective | 3 days |