PAP-NAP Device Clinical Study

This exploratory pilot clinical investigation is designed to evaluate the usability and short-term tolerability of the investigational positive airway pressure (PAP) device during a supervised daytime nap session in adults with obstructive sleep apnea (OSA) who are established continuous positive airway pressure (CPAP) users. The study focuses on early-stage human factors and usability assessment to support iterative device development and future clinical investigation planning.

Approximately 10-15 adult participants with diagnosed OSA who are currently using CPAP therapy will attend a single supervised in-clinic visit in a simulated bedroom environment. Participants will undergo device fitting and instruction before attempting a daytime nap of up to 90 minutes using the investigational device. During the session, trained study personnel will monitor participant safety and device performance through direct and/or remote observation.

The primary evaluation focuses on participant-reported usability outcomes, including comfort, seal, perceived weight, and ease of use. Secondary and exploratory assessments include ability to initiate sleep while using the device, observed sleep-related behaviours, session completion, tolerability, and descriptive sleep-related data collected from a contactless under-mattress monitoring device. Data collected from this study are intended to support design refinement, usability optimisation, and planning of future clinical studies involving wearable PAP technologies.

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