A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard care with a fixed pressure Continuous Positive Airway Pressure (CPAP) device and compared to a less aesthetically pleasing CPAP device without technologies (AutoCPAP, SensAwake™, ThermoSmart™) in patients previously diagnosed with moderate-severe obstructive sleep apnea (OSA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
HC244 devices without Thermosmart or SensAwake
Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™
APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™
Sleep HealthCenters
Brighton, Massachusetts, United States
Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software.
Time frame: On day 90 after randomization
Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit.
Time frame: On day 90 after randomization
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