Field Usability Study of Eclipse Mask

Study Overview
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Brief Summary
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The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device will be randomized.

Official Title
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Field Usability Study of Eclipse CPAP Device

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Eclipse novel CPAP mask
* Device: Phillips Respironics Nuance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: •Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device. Exclusion Criteria: Diagnosis of any medical or behavioral conditions that would compromise subject safety. Under the age of 18: target for this current version of the platform is the adult population.

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-House Usability Study Group<br>Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized. | Device: Eclipse novel CPAP mask<br>* Participants will follow instructions to set up and put on the Eclipse nasal mask. The Eclipse removes the headgear associated with traditional CPAP masks, offering a small compact design weighing less than an ounce. The Eclipse uses small and lightweight adhesive seals around the nostrils to create an ergonomic design which accommodates the shape of each individual user. It completes a perfect circuit for CPAP therapy to deliver pressure to the airway and stabilize the user's disordered breathing during sleep (apnea and snoring). Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.<br>Device: Phillips Respironics Nuance<br>* Participants will follow instructions to set up and put on the Respironics Nuance, traditional nasal mask. Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete each setup | We will record the time it takes the participant to set up and try on each device. | 1 day | 
| Number of technical issues | We will record the number of observed technical issues that occurred when the participant attempts to set up and try on the device. | 1 day | 
| Number of times participant needs assistance | We will record the number of times each participant requires assistance or additional instructions setting up and trying on each device. | 1 day |