PAP-NAP Device Clinical Study

This exploratory pilot study will evaluate the usability and short-term tolerability of the APL wearable positive airway pressure (PAP) device in adults during a supervised daytime nap session in a simulated sleep environment. The study is designed to assess participant experience with the investigational wearable PAP device, including comfort, fit and seal, perceived weight, ease of use, and ability to fall asleep while using the device. Participants will attend a supervised PAP-Nap session where they will use the wearable PAP device while resting or attempting to sleep. Study staff will also observe sleep-related behaviours, including sleep onset and session completion. Information collected from this study will help inform future development and refinement of wearable PAP technologies intended for the treatment of obstructive sleep apnea (OSA).

Inclusion Criteria: * Willing and able to provide written informed consent * Able to read and comprehend English * Aged 18 years or older * Currently using continuous positive airway pressure (CPAP) therapy for at least 3 months for treatment of obstructive sleep apnea (OSA) * Using CPAP mode with a fixed therapeutic pressure less than 16 cmH2O * Current user of a nasal mask interface and appropriately fitted to a medium-sized nasal mask * Agree to supervised monitoring, including video observation, during the nap session * Willing and able to attend a single in-clinic visit and attempt a supervised daytime nap of up to 90 minutes using the investigational device Exclusion Criteria: * Current use of bilevel positive airway pressure devices * Pregnant or possibly pregnant * Pre-existing lung disease or condition that may predispose to pneumothorax (e.g., chronic obstructive pulmonary disease \[COPD\], lung cancer, pulmonary fibrosis, recent pneumonia or lung infection within the past 2 years, or lung injury) * Active implanted medical devices that may interact with magnets, including pacemakers, implantable cardioverter defibrillators (ICDs), neurostimulators, cerebrospinal fluid shunts, or infusion pumps * Any condition or circumstance that, in the opinion of the investigator, could make participation unsafe or interfere with interpretation of study results * Currently enrolled in another clinical study