The purpose of this study is to evaluate the performance of a new type of mask, referred to as ‘Smart Mask’, for providing positive air pressure (PAP). This investigational product, which is not yet approved by the U.S. Food and Drug Administration (FDA), monitors motion and physiological parameters.
The study is divided into two ‘Phases’, each further subdivided into parts with specific procedures to evaluate different aspects of the Smart Mask.
Phase I (Individual Sensor Evaluation)
Phase II (Full Device Evaluation)