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.
Study Type
OBSERVATIONAL
Enrollment
35
Patients will be observed and asked a serious of questions while they put the mask on and after they remove it.
AeroFlow Sleep
Asheville, North Carolina, United States
Advanced Respiratory and Sleep Medicine
Huntersville, North Carolina, United States
Sleep Centers of Middle Tennessee
Murfreesboro, Tennessee, United States
Time to Complete Each Setup
The estimated time that it takes every subject to place the mask on their faces. Average of 3 trials per mask
Time frame: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
Number of Technical Issues That Occurred During the Trial
The total number of technical issues that the subject encountered while trying on either mask (average of 3 trials per mask)
Time frame: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
Number of Times Subjects Needed Additional Instructions
The amount of times that the subject needed help from the technician when placing either on either mask. Average of 3 trials per mask.
Time frame: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
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